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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/21/2023
Excerpt:
Non-Small Cell Lung Cancer: EGFR Exon 19 Deletion or Exon 21 L858R…First-line therapy...Osimertinib + pemetrexed + (cisplatin or carboplatin) (nonsquamous)…
Secondary therapy:
cisplatin + pemetrexed; carboplatin + pemetrexed
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
All patients with nonsquamous NSCLC...New or revised recommendations include the following: Osimertinib is the optimal first-line treatment for patients with activating epidermal growth factor receptor mutations (exon 19 deletion, exon 21 L858R, and exon 20 T790M)…
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
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: C2 – Inclusion Criteria
New
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
New
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....
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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
New
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
New
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
New
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
New
Title:

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

Excerpt:
...- Newly diagnosed, and histologically documented metastatic non-squamous NSCLC with sensitizing EGFR mutations positive, and classified as stage IV or recurrent NSCLC which are...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase 2 Study of Osimertinib in Combination with Platinum and Pemetrexed in Patients with Previously Untreated EGFR-Mutated Advanced Non-Squamous Non-Small Cell Lung Cancer: The OPAL Study

Published date:
03/02/2023
Excerpt:
This multicenter phase 2 trial evaluated the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer (NSCLC)….Patients received osimertinib 80 mg once daily (QD), with either cisplatin 75 mg/m2 (arm A) or carboplatin (area under the curve [AUC] = 5; arm B), plus pemetrexed 500 mg/m2 for four cycles and maintenance therapy of osimertinib 80 mg QD with pemetrexed 500 mg/m2 every 3 weeks....Overall, for patients with exon 19 deletions (n = 30), the ORR, median PFS, and median OS were 96.7% (95% CI, 90.2–100.0), 30.6 months (95% CI, 24.5–NR), and NR (95% CI, NR–NR). In contrast, for patients with exon 21 L858R (n = 35), the ORR, median PFS, and median OS were 85.7% (95% CI, 74.1–97.3), 33.4 months (95% CI, 18.9–NR), and NR (95% CI, NR–NR)...
Secondary therapy:
cisplatin; carboplatin + pemetrexed
DOI:
https://doi.org/10.1016/j.ejca.2023.02.023