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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care

Published date:
07/05/2024
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Secondary therapy:
Chemotherapy + pemetrexed
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
02/16/2024
Excerpt:
On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Evidence Level:
Sensitive: A1 - Approval
Title:

Tagrisso approved in the EU for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

Published date:
05/28/2021
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Evidence Level:
Sensitive: A1 - Approval
Title:

AstraZeneca’s Tagrisso: first medicine approved in the UK under Project Orbis

Published date:
05/07/2021
Excerpt:
Tagrisso (osimertinib) was approved for an indication extension…The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a licence extension for AstraZeneca’s Tagrisso (osimertinib), allowing it to be used in Great Britain as a monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Evidence Level:
Sensitive: A1 - Approval
Title:

Tagrisso approved in China for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

Published date:
04/14/2021
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC)...Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Evidence Level:
Sensitive: A1 - Approval
Title:

AstraZeneca Pharma India gets DCGI approval for osimertinib tablets

Published date:
03/11/2021
Excerpt:
AstraZeneca Pharma India has received import and market permission in Form CT-20 (subsequent New Drug Approval) from the Drugs Controller General of India for osimertinib 40mg/80mg film coated tablets (Tagrisso)….Osimertinib 40mg/80mg film coated tablets as monotherapy is now approved for additional indication for the adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Evidence Level:
Sensitive: A1 - Approval
Title:

Regulator OKs AZ’s Tagrisso as adjuvant therapy after lung cancer surgery

Published date:
02/25/2021
Excerpt:
AstraZeneca said Thursday the Ministry of Food and Drug Safety approved Tagrisso (ingredient: osimertinib) as an adjuvant treatment after complete tumor resection in early-stage epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer patients....with either an exon 19 deletion or exon 21 L858R substitutions.
Evidence Level:
Sensitive: A1 - Approval
Title:

Health Canada Approves Tagrisso (osimertinib) as First-line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

Published date:
07/12/2018
Excerpt:
AstraZeneca Canada today announced that Health Canada has approved Tagrisso (osimertinib) for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
TAGRISSO is a kinase inhibitor indicated...as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Evidence Level:
Sensitive: A2 - Guideline
Title:

Management of Stage III Non–Small-Cell Lung Cancer: ASCO Guideline

Published date:
12/22/2021
Excerpt:
Recommendation 4.2....Patients with resected stage III NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation may be offered adjuvant osimertinib after platinum-based chemotherapy (Type: Evidence based; benefit outweighs harm; Evidence quality: moderate; Strength of recommendation: strong).
DOI:
10.1200/JCO.21.02528
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
09/01/2021
Excerpt:
Osimertinib is indicated for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R substitution mutations [I, A].
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
The NCCN NSCLC Panel recommends osimertinib as a preferred first-line therapy option for patients with metastatic NSCLC who have sensitizing EGFR mutations based on the phase 3 trial and FDA approval….The presence of EGFR exon 19 deletions or exon 21 L858R mutations is predictive of treatment benefit from EGFR tyrosine kinase inhibitor (EGFR TKI) therapy (eg, osimertinib)...
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I-IIIA Completely Resected Non–Small-Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update

Excerpt:
Adjuvant osimertinib is recommended for patients with sensitizing EGFR (Ex19del or L858R) mutations...
DOI:
10.1200/JCO.22.00051
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR‑mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).

Published date:
05/25/2023
Excerpt:
Eligible patients (aged ≥18 years [≥20 in Japan and Taiwan], WHO PS 0/1 with completely resected EGFRm (ex19del/L858R) stage IB, II or IIIA [AJCC/UICC 7th edition] NSCLC; adjuvant chemotherapy allowed) were randomized 1:1 to osimertinib 80 mg once daily or placebo until disease recurrence...Adjuvant osimertinib demonstrated an unprecedented, highly statistically significant and clinically meaningful OS benefit in patients with EGFRm stage IB–IIIA NSCLC after complete tumor resection, with or without adjuvant chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2023.41.17_suppl.LBA3
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial

Published date:
01/31/2023
Excerpt:
Overall, 682 patients with stage IB-IIIA (American Joint Committee on Cancer/Union for International Cancer Control, seventh edition) EGFR-mutated (exon 19 deletion/L858R) NSCLC were randomly assigned 1:1 (stratified by stage, mutational status, and race) to receive osimertinib 80 mg once-daily or placebo for 3 years....These updated data demonstrate prolonged DFS benefit over placebo, reduced risk of local and distant recurrence, improved CNS DFS, and a consistent safety profile, supporting the efficacy of adjuvant osimertinib in resected EGFR-mutated NSCLC.
DOI:
10.1200/JCO.22.02186
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

First-line therapy in non-small cell lung cancer patients with EGFR activating mutations: a consideration of the clinical position of osimertinib based on the subset of Japanese patients in the FLAURA study

Published date:
04/22/2022
Excerpt:
In the double-blind phase III FLAURA study, 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion: Ex19del or p.Leu858Arg: L858R) advanced NSCLC were randomly assigned at a 1:1 ratio to receive either osimertinib or a comparator EGFR-TKI (gefitinib or erlotinib). The primary end point, median PFS, was significantly prolonged with osimertinib relative to comparator EGFR-TKI [18.9 vs. 10.2 months; hazard ratio (HR) for disease progression or death, 0.46; 95% confidence interval (95% CI), 0.37–0.57; P < 0.001].
DOI:
https://doi.org/10.1093/jjco/hyac012
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

85P-Adjuvant osimertinib in patients (pts) with stage IB-IIIAEGFR mutation-positive (EGFRm) NSCLC after complete tumour resection: ADAURA China subgroup analysis

Published date:
03/23/2022
Excerpt:
ADAURA enrolled adult pts with completely resected stage IB/II/IIIA NSCLC, EGFRm (Ex19del/L858R)...At DCO, stage II-IIIA DFS HR was 0.16 (95% CI: 0.08, 0.31, p<0.0001; maturity 40%); stage I-IIIA DFS HR was 0.18 (95% CI: 0.10, 0.33, p<0.0001; maturity 27%). ADFS benefit with osimertinib vs PBO was observed in all pre-specified subgroups of theChina cohort with sufficient events for analysis.
DOI:
https://doi.org/10.1016/j.annonc.2022.02.095
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

ADAURA: The Splash of Osimertinib in Adjuvant EGFR-Mutant Non-small Cell Lung Cancer

Published date:
03/16/2022
Excerpt:
ADAURA is a phase III, double-blind, placebo-controlled study that randomized (1:1) 682 patients with completely resected non-squamous...NSCLC with EGFR exon 19 deletions (del) or L858R mutations (alone or in combination with other EGFR mutations) to receive 80 mg of osimertinib or placebo for up to 3 years....The benefit with osimertinib was seen consistently across all predefined subgroups: type of EGFR mutation (HR 0.12 in exon 19 del, HR 0.35 in L858R), race (HR 0.22 in Asians, HR 0.17 in non-Asians), disease stage (HR 0.39 in stage IB, HR 0.17 in stage II and HR 0.12 in stage IIIA)...
DOI:
10.1007/s40487-022-00190-8
Evidence Level:
Sensitive: B - Late Trials
Title:

Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

Published date:
04/26/2021
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has been recommended for marketing authorisation in the European Union for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent. If approved, Tagrisso will be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

1401P - Osimertinib plus platinum/pemetrexed in newly-diagnosed EGFR mutation (EGFRm)-positive advanced NSCLC: Safety run-in results from the FLAURA2 study

Published date:
09/14/2020
Excerpt:
Thirty adults with confirmed EGFRm (ex19del/L858R) locally advanced/metastatic NSCLC, WHO PS 0/1, with no prior therapy for advanced disease, received osimertinib 80 mg QD, and either cisplatin 75 mg/m2 (n=15) or carboplatin AUC5 (n=15), plus pemetrexed 500 mg/m2 every 3 weeks (Q3W)...Osimertinib plus platinum/pemetrexed chemotherapy was generally well tolerated; no new safety signals were identified.
Secondary therapy:
cisplatin + pemetrexed; carboplatin + pemetrexed
Evidence Level:
Sensitive: B - Late Trials
Title:

Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.

Published date:
06/01/2020
Excerpt:
Eligible pts: ≥18 years (Japan/Taiwan: ≥20), WHO PS 0/1, primary non-squamous stage IB/II/IIIA NSCLC, confirmed EGFRm (ex19del/L858R)...2-year DFS rate was 90% with osimertinib vs 44% with PBO….Adjuvant osimertinib is the 1st targeted agent in a global trial to show a statistically significant and clinically meaningful improvement in DFS in pts with stage IB/II/IIIA EGFRm NSCLC...
DOI:
10.1200/JCO.2020.38.18_suppl.LBA5
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC

Published date:
01/02/2020
Excerpt:
In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group)....The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P=0.046).
DOI:
10.1056/NEJMoa1913662
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Published date:
08/22/2019
Excerpt:
FLAURA was a randomized (1:1), double-blind, international phase III study assessing the efficacy and safety of osimertinib (80 mg once daily) versus comparator first-generation EGFR-TKI (gefitinib 250 mg once daily or erlotinib 150 mg once daily) in patients with previously untreated, EGFRm-positive (Ex19del or L858R) locally advanced or metastatic NSCLC...The PFS superiority of osimertinib was consistent irrespective of the type of EGFR-sensitizing mutation at randomization: Ex19del, HR of 0.43 (95% CI, 0.32–0.56; P < 0.0001); L858R, HR of 0.51...
DOI:
10.1158/1078-0432.CCR-19-1126
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer

Excerpt:
In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation positive (exon 19 deletion or L858R) advanced NSCLC...The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001)....Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation positive advanced NSCLC...
DOI:
10.1056/NEJMoa1713137
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Liquid Biopsy as a Tool to Evaluate Resistance to First and Third (AZD9291) (EGFR) (TKIs) in (EGFR) Mutant NSCLC

Excerpt:
...Presence of EGFR activating mutations (exon 19 deletion or L858R in exon 21) 6....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Uncommon EGFR AZD9291

Excerpt:
...- Histologically confirmed metastatic or recurrent stage IV NSCLC with activating EGFR mutation other than deletion in exon 19, L858R, T790M and insertion in exon 20...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A randomized, open-label, multicenter, phase III study of osimertinib plus chemotherapy versus osimertinib monotherapy in EGFR active mutant NSCLC with concomitant mutation

Excerpt:
...NGS detection (targeting 150 genes) before treatment using tumor tissues indicating EGFR mutation (exon 19 deletion, or exon 21 L858R) and other concurrent mutations (TP53, Rb1, PTEN, Met, ERBB2, KRAS, BRAF, RET or ROS1); 8. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A multicenter, open-label, single arm pilot study: Osimertinib as neoadjuvant treatment for resectable stage II-IIIB EGFR mutant lung adenocarcinoma (NEOS)

Excerpt:
...Tested and confirmed to be EGFR mutation-positive (including exon 19 deletion and exon 21 L858R); 6. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-Line Treatment in Recurrent or Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm): A Phase II, Open Label, Single Arm, Multicenter, Exploratory&#32

Excerpt:
...According to the ARMS or Super-ARMS or NGS test results of tumor tissue or plasma from a certified laboratory approved by Chinese regulatory authorities, the tumor carries at least one of the 4 rare EGFR mutations (G719X/L861Q/S768I/T790M) (single mutation or compound mutation), but not other EGFR mutations (including ex19del/L858R). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

PET/CT imaging detect EGFR protein mutations of lung cancer with specific molecular probe 11C-AZD9291

Excerpt:
...EGFR mutation status was confirmed by ARMS fluorescence PCR, including 4 cases of 19del mutant, 4 cases of 21L858R mutant, and 2 cases of wild type; 3. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients WithnStage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection

Excerpt:
...These include exon 19 deletions, L858R (exon 21), G719X (exon 18), L861Q (exon 21), S768I (exon 20) and T790M (exon 20). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

Excerpt:
...Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Excerpt:
...A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

Excerpt:
...At least one documented uncommon EGFR mutation of G719X/L861Q/S768I/de novo T790M without EGFR Ex19del/L858R/exon 20 insertion as detected in tumour tissue, through real-time PCR or NGS analysis from accredited laboratories approved by the Chinese regulatory authority....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).

Excerpt:
...Pathologically confirmed non-small cell lung cancer (NSCLC) with documented EGFR sensitive mutation (EGFR 19del and L858R) positive before Osimertinib 1L....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Excerpt:
...- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

MEchanisms of resitance in EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtib Mécanismes de résistance chez des patients avec un cancer du poumon avancé non prétraité, EGFR muté, recevant un traitement par OSIMERTINIB

Excerpt:
...• The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC

Excerpt:
...EGFR activating mutations include exon19 deletion, T790M, L858R, G719X, L861Q, or S768I....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib In EGFR Mutant Lung Cancer

Excerpt:
...- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Osimertinib with or without Chemotherapy versus Chemotherapy alone as neoadjuvant therapy for Patients with Epidermal Growth Factor Receptor mutation positive resectable Non-Small Cell Lung Cancer

Excerpt:
...For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.- Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a Mulit-disciplinary Team (MDT) evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).`...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI

Excerpt:
...Histologically documented that with sensitizing EGFR mutations(either L858R or Exon19del) 7....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Clinical Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy Uno studio clinico di lazertinib con amivantamab per via sottocutanea somministrato tramite iniezione manuale rispetto ad amivantamab per via endovenosa o ad amivantamab per via sottocutanea in pazienti con carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR dopo progressione durante il trattamento con osimertinib e chemioterapia

Excerpt:
...Have histologically or cytologically confirmed, advanced or metastatic NSCLC, characterized by either EGFR Exon 19del or Exon 21 L858R mutation by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory or an accredited local laboratory. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations

Excerpt:
...- Patient with common EGFR mutation-positive (exon 19 deletion or L858R mutation, alone or co-occuring with other EGFR mutations)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)

Excerpt:
...Presence of a common EGFR mutation (Del19 or L858R)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib

Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

Excerpt:
...- Documented activating EGFR mutation (Exon 19 deletion, T790M, or L858R) on tumor samples by Clinical Laboratory Clinical Laboratory Improvement Amendments (CLIA)-approved test...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

Excerpt:
...As confirmed by the central laboratory, the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M; 7....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study

Excerpt:
...- NSCLC which harbors EGFR exon 19 deletion or L858R mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

Excerpt:
...L858R, exon 19 deletions, exon 19 insertions, L861Q, G719X....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)

Excerpt:
...Presence of the sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.

Excerpt:
...Patients with EGFR sensitizing mutations (Ex19del or L858R)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

this trial is finalized to evaluate the tolerability and the quality of life in patients with Lung cancer who take AZD9291 Questa sperimentazione ¿ finalizzata a valutare la tollerabilit¿ e l'impatto sulla qualit¿ della vita dei pazienti affetti da tumore polmonare che assumono AZD9291

Excerpt:
...Patients must fulfil one of the following:• Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)• OR• Must have experienced clinical benefit from EGFR-TKI, according to the Jackman criteri (Jackman et al 2010) followed by systemic objective progression (RECIST or WHO) while on continuous treatment with EGFR TKI7. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)

Excerpt:
...- Have confirmation of the presence of common EGFR mutations (exon 19 deletion, L858R/exon 21, or G719X) through any locally and internationally accepted standard tests....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Excerpt:
...- The tumor harbors an Ex19del or Ex21-L858R substitution (based on tumor tissue or plasma [ctDNA] assessment)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib

Excerpt:
...History of EGFRm (exon 19 deletion or exon 21 L858R) in the plasma ctDNA by the local testing methods....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Excerpt:
...- Presence of sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations

Excerpt:
...Documented activating EGFR mutation (Exon 19 deletion or L858R) 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

Excerpt:
...- Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase III Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib,Carboplatin and Pemetrexed for Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations

Excerpt:
...Histologically or cytologically confirmed stage IV or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations; 6....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

Excerpt:
...- Patients with a EGFR deletion or mutation in exon 19, exon 21 (L858R, L861Q) or exon 18 (G719X) and concomitant T790M mutation before treatment confirmed centrally....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase I, Study in Chinese NSCLC Patients

Excerpt:
...- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) 6....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy

Excerpt:
...Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD ≥6 months) from EGFR-TKIs and had developed progressive disease following those therapy...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

Excerpt:
...The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing (cobas® v2 only)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer

Excerpt:
...Group 1: Patient had a documented EGFR Exon 19del or L858R activating mutation and progressed while on osimertinib as first-line therapy in the advanced/metastatic setting....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

AZD9291 First Time In Patients Ascending Dose Study

Excerpt:
...- Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or T790M EGFR resistance mutation as assessed by local laboratory/or central laboratory via tissue/cytology or in plasma....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Excerpt:
...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R)....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases

Excerpt:
...- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Osimertinib in First and Second Line Treatment of NSCLC Harboring EGFR Mutations From Circulating Tumor DNA

Excerpt:
...Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating tumor DNA either by PANA mutyper® or Cobas® EGFR mutation test....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

Excerpt:
...The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Efficacy study of osimertinib in treatment-naïve patients with EGFR mutant NSCLC according to TP53 mutational status (TEMPLE-2) Studio sull’efficacia di Osimertinib in prima linea nei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53 (TEMPLE-2)

Excerpt:
...o Provision of informed consent prior to any study specific procedures.o Patients (male/female) must be > 18 years of age.o Locally advanced or metastatic EGFR mutant NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of EGFR exon 19 deletion or exon 21 p.L858R.o Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow central analysis.o Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with osimertinib. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene. Un estudio clínico que explora el efecto del osimertinib y la radioterapia en personas con cáncer de pulmón de células no pequeñas (CPCNP) recién diagnosticado que se ha diseminado a algunas otras partes del cuerpo y muestra un cambio (mutación) en el gen EGFR.

Excerpt:
...1) Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.2) Presence of sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory.3) Synchronous oligo-metastatic stage IV disease (max 5 lesions)4) Measurable disease as defined according to RECIST v1.15) All lesions amenable for radical radiotherapy according to local judgment6) ECOG performance status 0-27) Adequate haematological, renal and liver function 1) CPNM con mutación EGFR sin tratamiento, confirmado histológicamente, con o sin mutación de resistencia T790M.2) Presencia de mutación EGFR sensibilizante (deleción del exón 19 y / o exón 21 L858R) detectada por un laboratorio acreditado.3) Enfermedad sincrónica oligo-metastásica en estadio IV (máximo 5 lesiones)4) Enfermedad medible según se define de acuerdo con RECIST v1.15) Todas las lesiones susceptibles de radioterapia radical según el criterio local.6) estado funcional ECOG 0-27) Función hematológica, renal y hepática adecuada`- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.- Presence of sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory.- Synchronous oligo-metastatic stage IV disease (max 5 lesions).- Measurable disease as defined according to RECIST v1.1.- All lesions amenable for radical radiotherapy according to local judgment.- ECOG performance status 0-2.- Adequate haematological, renal and liver function. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A late stage clinical trial to investigate the efficacy and safety of Osimertinib versus Placebo in patients with stage IA2-IA3 non-small cell lung cancer, following complete tumour resection. Ensayo clínico para investigar la eficacia y seguridad de Osimertinib versus Placebo en pacientes en estadío IA2-IA3 de cáncer de pulmón no microcítico, tras la resección completa del tumor.

Excerpt:
...A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R).9. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Resistance to the Tyrosine Kinase Inhibitor Osimertinib and Pharmacokinetics in Non-small Cell Lung Cancer

Excerpt:
...- Tumor with an activating mutation of EGF-R (deletion of exon 19 or L858R, L861x, or G719x mutation)...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase II study of 5 years of adjuvant osimertinib in completely resected EGFRm NSCLC Estudio de fase II de 5 años del tratamiento adyuvante con osimertinib en el cáncer de pulmón no microcítico con mutación del receptor del factor de crecimiento epidérmico completamente resecado.

Excerpt:
...Staging will be according to the pTNM (pathologic tumour,node, metastasis) staging system for lung cancer 8) Confirmation by the local laboratory that the tumour harbours 1 of the following EGFRmutations:-1 of the 2 common EGFR mutations (Ex19del, L858R), either alone or incombination with other EGFR mutations including de novo T790M and excluding allexon 20 insertions (Common EGFRm Cohort); or - Uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).9) Complete surgical resection of the primary NSCLC is mandatory. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1326P - Osimertinib in patients with EGFR-mutated NSCLC and leptomeningeal or brain metastases: Results of the IFCT-1804 ORBITAL trial

Published date:
10/16/2023
Excerpt:
ORBITAL is a multicenter phase II trial investigating the efficacy and safety of osimertinib 80 mg/d in EGFR-mutated NSCLC patients with leptomeningeal metastases (cohort 1) or patients with brain metastases who have not received prior EGFR-Tyrosine kinase inhibitor or radiation therapy (cohort 2)....EGFR mutations were mostly del19 (60.4%) and L858R (30.2%)....Osimertinib demonstrated clinically meaningful responses in patients with EGFR-mutated NSCLC against both leptomeningeal and brain metastases.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase II Study of Osimertinib in Patients with Advanced-Stage Non-Small Cell Lung Cancer following Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) Therapy with EGFR and T790M Mutations Detected in Plasma Circulating Tumour DNA (PLASMA Study)

Published date:
10/16/2023
Excerpt:
PLASMA is a prospective, open-label, multicentre single-arm Phase II study. Patients with advanced NSCLC harbouring sensitizing EGFR and T790M mutations in plasma at progression from ≥one 1G/2G TKI were treated with 80 mg of Osimertinib daily until progression....The ORR was 50.9% (95% CI 41.2-60.6) and the DCR was 84.5% (95% CI 76.4-90.7). Median PFS was 7.4 (95% CI 6.0-9.3) months; median OS was 1.63 (95% CI 1.35-2.16) years....Osimertinib is active in NSCLC harbouring sensitizing EGFR and T790M mutations in ctDNA testing post 1G/2G TKIs.
DOI:
https://doi.org/10.3390/cancers15204999
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of Osimertinib (OSI) vs 1st-Generation TKI Followed by OSI by Clinical Profile in EGFR-Mutant NSCLC (SMILE STUDY)

Published date:
08/08/2023
Excerpt:
This retrospective multicenter study included patients with mEGFR (ex19/ex21) aNSCLC treated with either osimertinib or the sequence of 1G followed by osimertinib (“sequence group”)... In this real-life study we showed that osimertinib upfront demonstrated prolonged 1L-PFS vs. 1G followed by osimertinib, with better PFSglob in patients with poor-prognosis mEGFR aNSCLC.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Drug Tolerant Persister Cells to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer Harboring EGFR Mutations (NORA)

Published date:
08/08/2023
Excerpt:
EGFR mutations included exon 19 del (N=10, 40%) and L858R (N=15, 60%). After 2 cycles of neoadjuvant osimertinib, ORR was 44% (N=11, all partial response) and the remaining 56% (N=14) had stable disease. The MPR rate was 24% (N=6)…In patients with resectable EGFR-mutant NSCLC, neoadjuvant osimertinib is a feasible option that was not associated with surgical delays and induced MPR rate of 24% of resected tumors.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical and financial implications of ADUARA trial on a real-world population.

Published date:
05/25/2023
Excerpt:
...we have evaluated the hypothetical clinical and financial effects of adj osimertinib on the early-stage, EGFRm NSCLC patients at Cleveland Clinic who were treated prior to the FDA approval....82 patients were EGFRm+ (exon 19 deletion or the L858R mutation), and their survival outcomes were used in the SOC arm. At 5 years, 32 (39%) of the patients were alive and disease free. With the addition of adj osimertinib, an estimated average of 61 (71.4%) of patients would have been disease free and alive.
DOI:
10.1200/JCO.2023.41.16_suppl.8526
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LB123 / 6 - Poorer outcomes in EGFR L858R-driven NSCLC treated with osimertinib may be addressed with novel combination of BLU-945 and osimertinib

Published date:
03/15/2023
Excerpt:
CONTRADICTING EVIDENCE: Both RWDs confirmed poorer prognosis for 1L osimertinib-treated patients with L858R vs ex19del. MDACC cohort showed a 12-mo PFS rate of 63% for L858R (n=45) vs 82% for ex19del (n=60); mPFS was immature….In both RWDs, 1L osimertinib-treated patients with L858R-driven NSCLC had poorer outcomes vs ex19del, consistent with osimertinib’s weaker activity on L858R.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A phase II study (WJOG12819L) to assess the efficacy of osimertinib in patients with EGFR mutation-positive NSCLC in whom systemic disease (T790M-negative) progressed after treatment with first- or second-generation EGFR TKIs and platinum-based chemotherapy

Published date:
01/27/2023
Excerpt:
We conducted a phase II study to assess the efficacy of osimertinib in patients with EGFR mutation-positive NSCLC....The most common sensitizing mutations at baseline were deletions in exon 19 (50.9 %) and the L858R point mutation in exon 21 (40.0 %)….Patients received osimertinib, 80 mg/day, every day until disease progression...the overall response rate was 29.1 % (95 % CI, 17.6–42.9), which exceeded the necessary threshold response rate for primary analysis. Stable disease was found in 16 patients (29.1 %)....The median length of PFS was 4.07 months (95 % CI, 2.10–4.30), and the rate of 12-month PFS was 17.3 % (95 % CI, 8.6–28.6).
DOI:
https://doi.org/10.1016/j.lungcan.2023.01.011
Evidence Level:
Sensitive: C3 – Early Trials
Title:

363P - A multicentre, real-world observational study of efficacy and safety of first-line osimertinib treatment in patients with epidermal growth factor receptor (EGFR) activating mutation-positive advanced non-small cell lung cancer (Reiwa study)

Published date:
11/28/2022
Excerpt:
EGFR mutation-positive NSCLC patients who started EGFR-TKI treatment from September 2018 to August 2020 were enrolled, and first-line osimertinib monotherapy was selected among them....The median progression-free survival (PFS) was 20.0 months (95% CI: 17.6-21.7) and the survival rate at 24 months was 72.4% (95% CI: 68.4-76.0). The PFS by mutation type was 23.5 months (95% CI: 20.9-27.4) for exon 19 deletion and 17.0 months (95% CI: 15.2-19.7) for L858R point mutation in exon 21....Osimertinib showed promising activity with a manageable safety profile in clinical practice, even for patients with poor PS, consistent with effects to previous clinical trials.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1123P - Real-world outcomes of first-line osimertinib for EGFR mutated advanced NSCLC patients in China: Interim analysis of the FLOURISH study

Published date:
09/05/2022
Excerpt:
Eligible patients with EGFRm (19del or L858R) advanced NSCLC who has received osimertinib monotherapy as first-line therapy were enrolled from 24 sites in China....ORR was 60.0%, DCR was 96.3%. After a median follow-up of 10.2 months, the 1-year PFS rate was 78.8% (95%CI, 66.9-86.8).
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Mechanisms of Resistance to First-Line Osimertinib in Hispanic Patients With EGFR Mutant Non-Small Cell Lung Cancer (FRESTON-CLICaP)

Published date:
06/04/2022
Excerpt:
This is a multicenter, multinational, retrospective cohort study of Hispanic patients treated with Osimertinib as first-line for EGFR-mutated NSCLC....Identified mutations included EGFR Exon 19 deletions and EGFR pL858R point mutations. Median progression-free survival (PFS) was 14.4 months (95%CI 12.4-18.2 months)….Treatment with first line osimertinib represents an effective and safe option for Hispanic patients with metastatic NSCLC.
DOI:
10.1016/j.cllc.2022.06.001
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A real-world study of patient characteristics and clinical outcomes in EGFR-mutated lung cancer treated with first-line osimertinib

Published date:
05/26/2022
Excerpt:
We report a single academic center’s experience with real-world osimertinib use in unresectable EGFR-mutated NSCLC...Regarding EGFR mutation, 32 (57%) had exon 19 deletion and 16 (29%) had exon 21 L858R mutation...Median OS for all patients was 32.0 months (95% CI 15.7 – NR) and not reached for the FLAURA-eligible cohort....Outcomes in our real-world FLAURA-eligible patients were better than previously reported.
DOI:
10.1200/JCO.2022.40.16_suppl.e21033
Evidence Level:
Sensitive: C3 – Early Trials
Title:

The Difference in Clinical Outcomes Between Osimertinib and Afatinib for First-Line Treatment in Patients with Advanced and Recurrent EGFR-Mutant Non-Small Cell Lung Cancer in Taiwan

Published date:
04/23/2022
Excerpt:
We retrospectively analyzed patients with advanced and recurrent non-small cell lung cancer who harbored an exon 19 deletion or an exon 21 L858R mutation….The median progression-free survival was 18.8 months and 13.1 months in the osimertinib and afatinib groups, respectively (hazard ratio 0.75 [95% confidence interval 0.48-1.18])....In patients with brain metastasis at baseline, the median progression-free survival was 22.1 months in the osimertinib group, and 10.9 months in the afatinib group (adjusted hazard ratio 0.45 [95% confidence interval 0.21-0.96])...there was a statistical significance revealing that osimertinib provided better median progression-free survival than afatinib in patients with brain metastasis at baseline.
DOI:
10.1007/s11523-022-00878-x
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Therapeutic effect of osimertinib plus cranial radiotherapy compared to osimertinib alone in NSCLC patients with EGFR-activating mutations and brain metastases: a retrospective study

Published date:
12/05/2021
Excerpt:
The clinical data of advanced NSCLC patients with BMs who received osimertinib were retrospectively collected....The patients were assigned to one of the two groups according to the therapeutic modality used: the osimertinib monotherapy group or the osimertinib plus RT group....In the L858R mutational subgroup of 31 patients, the osimertinib plus RT group had a longer OS (P = 0.046). In the exon 19 deletion mutational subgroup of 30 patients, OS in the osimertinib alone group was longer than that in the osimertinib plus RT group (P = 0.011).
DOI:
10.1186/s13014-021-01955-7
Evidence Level:
Sensitive: C3 – Early Trials
Title:

First-line osimertinib for poor performance status patients with EGFR mutation-positive non-small cell lung cancer: A prospective observational study

Published date:
11/22/2021
Excerpt:
We assessed the clinical effects of osimertinib as a first-line treatment for patients with poor PS NSCLC with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered osimertinib (80 mg/day) as the initial treatment….The overall objective response rate was 56.3%. The median progression-free survival (PFS) of the entire patient population was 10.5 months and the PS score improved in 8 of 16 patients (50%)....Considering the findings of this study, osimertinib appears to be an effective and safe treatment option for patients with poor PS and advanced NSCLC harboring sensitive EGFR mutations.
DOI:
10.1007/s10637-021-01195-2
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

Published date:
11/20/2021
Excerpt:
We assessed the clinical effects of osimertinib as a first-line treatment for elderly NSCLC patients (≥75 years of age) with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered 80 mg/day osimertinib as initial treatment....The overall objective response rate was 60.5%. The median progression-free survival (PFS) and time to treatment failure (TTF) of the entire patient population were 22.1 months and 14.6 months, respectively.
DOI:
10.2147/CMAR.S339891
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

VP3_2021 - A randomized phase II study of second-line osimertinib (Osi) and bevacizumab (Bev) versus Osi in advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and T790M mutations (mt): Results from the ETOP BOOSTER trial

Published date:
09/13/2021
Excerpt:
...combined Osi/Bev versus Osi in pts with NSCLC with EGFR-mt (exon 19 del or L858R) and T790M-mt at progression on prior EGFR TKI...the median PFS was 15.4m (95% CI 9.2-18.0) and 12.3m (6.2-17.2) (PFS events: 64 & 65) in the Osi/Bev and Osi arm respectively (HR 0.96; 0.68- 1.37; p=0.83). Median OS was 24.0m (17.8-32.1) in Osi/Bev and 24.3m (16.9-37.0) in Osi arm (deaths: 46 & 43) (HR 1.03; 0.67-1.56; p=0.91). ORR was 55% in both arms.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P51.05 - Sequential Afatinib and Osimertinib in Patients With Advanced EGFRm+ NSCLC and Acquired T790M: The Real-World UpSwinG study

Published date:
08/18/2021
Excerpt:
In this non-interventional, global, multi-center study (NCT04179890), existing medical or electronic health records were identified for consecutive EGFR TKI-naïve patients with EGFRm+ NSCLC (Del19 or L858R) treated in regular clinical practice with first-line afatinib and, following the detection of T790M, second-line osimertinib. ORR with afatinib and osimertinib was 74% and 45%. TTF, OS and ORR were generally consistent across subgroups.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P26.02-A Phase II Trial of Neoadjuvant Osimertinib for Surgically Resectable EGFR-Mutant Non-Small Cell Lung Cancer: Updated Results

Published date:
08/18/2021
Excerpt:
As of April 2021, 13 patients with early-stage (6 stage IA/B, 2 Stage IIA/B, and 5 Stage IIIA) EGFR-mutant (7 exon 19 del, 6 L858R) NSCLC have been enrolled and treated with osimertinib for an average of 59 days prior to surgical resection. The mPR rate was 15% (2 of 13). The pathological response rate was 69% (9 of 13).
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Overall survival comparison in patients with and without brain metastases treated with osimertinib for metastatic EGFR mutation positive non-small cell lung cancer (NSCLC)

Published date:
05/19/2021
Excerpt:
...patients diagnosed with metastatic non-small cell lung cancer (NSCLC) with EGFR mutation...82.2% of this patient population received Osimertinib...EGFR mutation sub-groups, the median OS for patients with EGFR-exon 19-deletion was 26.4 months (95% CI [14.3 – 38.4 months], compared to 36.8 months, 95% CI [34.3 – 39.2 months] for those with EGFR-Exon 21-L858R...
DOI:
10.1200/JCO.2021.39.15_suppl.e21216
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

149P - First line (1L) osimertinib in EGFR mutant (mut) advanced non-small-cell lung cancer (aNSCLC) patients (pts): progression (PD) pattern and safety in the real-world (RW)

Published date:
03/17/2021
Excerpt:
This is an observational, multicenter study enrolling EGFR mut aNSCLC receiving 1L osimertinib...82 pts receiving osimertinib were included in 3 centres...Baseline EGFR mutations were exon 19 deletion in 39 (47.6%) pts, L858R in 36 (43.9%) pts, others in 7 (8.6%) pts...Median follow-up was 11.2 months (mo). Response rate was 68.3%, disease control rate 86.6%. mPFS was 22.0 mo (95%CI, 11.4–32.5), mTTF 25.3 mo (95%CI, 18.9-not calculable).
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study

Published date:
02/05/2021
Excerpt:
Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R) advanced NSCLC were enrolled...Osimertinib extended median PFS by 8.0 months versus comparator EGFR TKI (17.8 vs. 9.8 months; hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.37-0.85). Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29).
DOI:
10.1007/s11523-021-00794-6
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

FP14.16 - Phase 2 Trial of the Alternating Therapy with Osimertinib and Afatinib for Treatment-Naive Patients with EGFR-Mutated Advanced Non–Small Cell Lung Cancer (WJOG10818L/Alt Trial)

Published date:
01/12/2021
Excerpt:
Patients with treatment-naive stage IV EGFR-mutated (L858R or del19) NSCLC were enrolled. Orally osimertinib 80 mg once a day for 8 weeks, followed by afatinib 20 mg once a day for 8 weeks, which was repeated alternately….The ORR and one-year survival rate were 69.6% (95% CI: 54.2%-82.3%) and 93.48% (95% CI: 81.13%-97.85%), respectively….Although current study didn’t meet the primary endpoint of one-year PFS rate, alteration therapy with osimertinib and afatinib demonstrated promising efficacy...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Survival Analyses and Molecular Predictors of Outcomes in Patients Treated with Osimertinib for Metastatic NSCLC Harboring EGFR Mutation

Published date:
01/12/2021
Excerpt:
...consecutive patients with metastatic NSCLC-EGFR mutations, treated with Osimertinib 80 mg once daily...Among the 56 patients treated with Osimertinib, the median DFS for those who had an EGFR mutation on exon 21-L858R was 15.2 months (95% confidence interval [CI] 11.3 - 19.0 months)...The median OS was 52.6 months in the exon 21-L858R group (95% [CI] 35.4 - 69.7 months...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study

Published date:
08/28/2020
Excerpt:
Data were collected between December 2017 and December 2019 for patients with EGFR mutation-positive (Del19 and L858R) NSCLC who had T790M-positive disease after first-line afatinib and subsequently received osimertinib...Overall median OS was 37.6 months (90% CI: 35.5–41.3) with a 2-year survival rate of 80% (Figure 2A). Median OS was 44.8 months (90% CI: 37.0–57.8) in Asian patients and 41.6 months (90% CI: 36.9–45.0) in patients with Del19-positive disease...
DOI:
https://doi.org/10.2217/fon-2020-0740
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Final analysis of a phase II, open label, randomized study of osimertinib versus osimertinib plus carboplatin/pemetrexed for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with previous EGFR-TKI and whose tumours harbour a T790M mutation (LOGIK1604/NEJ032A).

Published date:
05/28/2020
Excerpt:
From October 2016 to January 2019, 62 pts were enrolled [31 pts osimertinib; 31 pts combination] (median age 68 (37-80); 53.2% male; 83.3% stage IV; 100% adenocarcinoma; 59.7% exon 19 deletion and 40.3% L858R; 45.2% never smoker)....Combination of osimertinib with carboplatin and pemetrexed demonstrated safety in patients with EGFR and T790M mutation-positive NSCLC and the efficacy should be validated in the future phase 3 study.
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1200/JCO.2020.38.15_suppl.e21594
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EGFR mutation genotypes affect efficacy and resistance mechanisms of osimertinib in T790M-positive NSCLC patients

Published date:
03/13/2020
Excerpt:
CONTRADICTING EVIDENCE: Similarly, multivariate analysis also confirmed that L858R (HR=1.70, 95% CI: 1.06–2.73, P=0.026) was independently associated with worse OS than EGFR ΔE746 mutation subtype (Table S3).
DOI:
10.21037/tlcr.2020.03.35
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Leptomeningeal Metastatic L858R EGFR-mutant Lung Cancer: Prompt Response to Osimertinib in the Absence of T790M-mutation and Effective Subsequent Pulsed Erlotinib

Published date:
06/14/2022
Excerpt:
We present a 52-year-old male patient with metastatic non-small-cell lung cancer (NSCLC). The patient was found to have L858R mutation in exon 21 of the EGFR gene….osimertinib (160 mg once daily) promptly induced clinical and radiological response that continued for five months. High dose pulsed erlotinib (1500 mg weekly) improved his quality of life and extended his survival for a further four months.
DOI:
https://doi.org/10.2147/OTT.S336012
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Osimertinib as induction therapy for oligometastatic non-small cell lung cancer with EGFR mutation: a case report

Excerpt:
This is the first case report about uniportal video-assisted thoracic surgery after induction therapy of TKI for OM-NSCLC....Next-generation sequencing found an EGFR mutation (exon 21 p.L858R missense), and osimertinib, a third-generation TKI, was used 80 mg per day as the induction therapy due to the EGFR mutation detected from the metastatic tumor. A favorable treatment response was observed of the lung tumor with lymph node regression...
DOI:
10.21037/tlcr-22-251
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Emergence of novel and dominant acquired EGFR solvent-front mutations at Gly796 (G796S/R) together with C797S/R and L792F/H mutations in one EGFR (L858R/T790M) NSCLC patient who progressed on osimertinib

Excerpt:
A 69-year-old Caucasian female former light-smoker presented with stage IV EGFR L858R positive adenocarcinoma who developed EGFR T790M mutation after 8 month treatment of erlotinib. The patient was initiated on osimertinib with disease shrinkage after 2 months, but tumor regrowth was observed after 5 months of osimertinib treatment.
DOI:
https://doi.org/10.1016/j.lungcan.2017.04.003