A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive S… (NCT04426825) | Clinical Trial Compass
CompletedPhase 2
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
China23 participantsStarted 2020-09-09
Plain-language summary
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Life expectancy ≥ 10 months
* Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
* No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:
Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.
* TKIs approved for treatment of NSCLC discontinued \>7 days prior to enrollment.
* Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
* ECOG Performance Status of 0-1
* Adequate hematologic and end-organ function
* Negative HIV test at screening
* Negative hepatitis B surface…