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    Association details:
    Biomarker:EGFR L858R
    Cancer:Lung Cancer
    Drug:Tagrisso (osimertinib) (EGFR inhibitor)
    Direction:Resistant
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

    Excerpt:
    the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and 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
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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....
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2022-000525-25
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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). ...
    Trial ID:
    ChiCTR2100054167
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    ChiCTR2100044457
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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). ...
    Trial ID:
    ACTRN12623000552684
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2021-003024-33
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2018-003218-42
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    TARGET
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    ADAURA2
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    NCT05546866
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    GPS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    NCT03122717
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT05805631
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT03586453
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT05528458
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    POSITHES
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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
    Source:
    clinicaltrials.gov
    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:
    ROSIE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    MELROSE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    NCT03433469
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NORTHSTAR
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    ORBITAL
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    Source:
    clinicaltrials.gov
    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:
    STEREO
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ......
    Trial ID:
    NCT05948813
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...Patients with EGFR sensitizing mutations (Ex19del or L858R)....
    Trial ID:
    NCT06018688
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    CULTRO
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    NCT04591002
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT05693090
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

    Excerpt:
    ......
    Trial ID:
    NCT05583409
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    FLAME
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT02954523
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NORA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT04829019
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT03769103
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    TOP
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    AZENT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT02771314
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrials.gov
    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:
    KCSG-LU15-09
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    ChiCTR1800016948
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    ChiCTR2100045604
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2021-004135-89
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2020-004114-35
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    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. ...
    Trial ID:
    2020-001879-33
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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
    Source:
    clinicaltrials.gov
    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)...
    Less C2 evidence
    Evidence Level:
    Resistant: C4 – Case Studies
    Source:
    Curr Oncol
    Title:

    Efficacy of Osimertinib in Lung Squamous Cell Carcinoma Patients with EGFR Gene Mutation–Case Report and a Literature Review

    Published date:
    05/13/2022
    Excerpt:
    The hereby presented patient fitted the ADC characteristics, while they were diagnosed with SCC. The unusual diagnosis implied further genetic testing, which established the occurrence of L858R substitution in exon 21 in the EGFR gene….Due to EGFR gene mutation, the woman was administered osimertinib, however, the treatment did not succeed...The patient died 10 months after diagnosis.
    DOI:
    https://doi.org/10.3390/curroncol29050285