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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A multicentre phase II, open-label, non-randomized study evaluating Platinum-Pemetrexed-Atezolizumab ( Bevacizumab) for patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutations, ALK rearrangement or ROS1 fusion progressing after Targeted therapies Étude multicentrique de phase II, ouverte, non randomisée, de phase II, évaluant le Platine-Pemetrexed-Atezolizumab (Bevacizumab) chez des patients atteints d'un cancer du poumon non à petites cellules non épidermoïde de stade IIIB/IV avec mutation EGFR, réarrangement ALK ou fusion ROS1, qui évolue après des traitements ciblés

Excerpt:
...• Patient older than 18 years and no more than 75 year-old • Subject affiliated to an appropriate social security system • Signed informed consent before any trial related activities and according to local guidelines • ECOG performance status of 0 or 1 • Histologically or cytologically confirmed, stage IIIB/IV non-squamous NSCLC (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 7th edition) • Patient with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, osimertinib or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC • Patient with an ALK fusion oncogene (confirmed in local laboratory) must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e., crizotinib, alectinib, ceritinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene • Patient with a ROS1 fusion oncogene (confirmed in local laboratory) must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ROS inhibitors (i.e., crizotinib,) appropriate for the treatment of NSCLC in patients having an ROS1 fusion oncogene • No prior chemotherapy treatment for Stage IV non-squamous NSCLC except if less than 3 cycles, with treatment free-interval of at least 1 year from inclusion since last chemotherapy • Patient who has received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from inclusion since the last chemotherapy, radiotherapy, or chemoradiotherapy • Patient with an history of treated asymptomatic CNS metastases is eligible •Measurable disease, as defined by RECIST v1.1 •Adequate hematologic and end-organ function •Adequate method of contraception during the treatment period and at least 5 months after the last dose of atezolizumab or 6 months after the last dose of chemotherapy • Patient âgé de 18 ans et pas plus de 75 ans • Sujet affilié à un système de sécurité sociale • Consentement éclairé signé avant tout acte lié à l'essai • Indice de performance (ECOG) 0-2. ...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Atezolizumab with or without bevacizumab and platinum-pemetrexed in patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutation, ALK rearrangement or ROS1 fusion progressing after targeted therapies: A multicentre phase II open-label non-randomised study GFPC 06-2018

Published date:
01/29/2023
Excerpt:
Patients received platinum, pemetrexed, atezolizumab, bevacizumab (PPAB cohort)....EGFR mutation, 87.3%/89.7%; ALK rearrangement, 12.7%/5.1%; ROS1 fusion, 0%/6.4%, respectively)....After 12 weeks, objective response rate was 58.2% (90% confidence interval [CI], 47.4-68.4) in PPAB cohort and 46.5% (90% CI, 36.3-56.9) in PPA cohort. Median progression-free survival and overall survival were 7.3 (95% CI 6.9-9.0) months and 17.2 (95% CI 13.7-NA) months in PPAB cohort and 7.2 (95% CI 5.7-9.2) months and 16.8 (95% CI 13.5-NA) months in PPA cohort, respectively....Combination approach with atezolizumab with or without bevacizumab and platinum-pemetrexed achieved promising activity in metastatic EGFR-mutated or ALK/ROS1-rearranged NSCLC after tyrosine kinase inhibitor failure, with acceptable safety profile.
Secondary therapy:
Chemotherapy + pemetrexed
DOI:
https://doi.org/10.1016/j.ejca.2023.01.014
Trial ID: