Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK … (NCT03991403) | Clinical Trial Compass
UnknownPhase 3
Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC
South Korea228 participantsStarted 2019-08-27
Plain-language summary
This randomized, Phase III, multicenter, open-label study designed to evaluate the efficacy of Atezolizumab in combination with carboplatin, paclitaxel, bevacizumab compared with treatment with pemetrexed, cisplatin in approximately 228 TKI(tyrosine kinase inhibitor) pre treated patients with Stage IV non squamous non small cell lung cancer with activating EGFR mutation or ALK translocation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Male or female, 18 years of age or older
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 8th edition).
* Patients with tumors of mixed histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous.
* As the stage IV non-squamous NSCLC treatment, no prior cytotoxic treatment is allowed and the patients treated with below tyrosine kinase inhibitor prior to the enrollment
* Patients with a sensitizing mutation in the epidermal growth factor receptor (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 tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFR mutant NSCLC.
If the patients have identified T790M mutation after 1st or 2nd generation EGFR TKI failure, the patient must be treated with the second line 3rd generation EGFR TKI treatment, such as osimertinib, before the study participation.
Patients with an anaplastic lymphoma kinase (ALK) fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e., crizotinib) appropriate for the treatment of NSCLC in patie…
What they're measuring
1
progression-free survival, PFS
Timeframe: 34month after the first patient is randomized