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.
Name: Atezolizumab(Tecentriq)
Description: Atezolizumab(1200 mg IV);Over 60 (± 15) min (for the first infusion); 30 (± 10) min for subsequent infusions if tolerated Frequency: Day 1 of every 21 days Induction: Four or Six Cycles Maintenance : until PDType: DrugAtezolizumab group
Name: Pemetrexed
Description: Induction Period (Four or Six Cycles) (1) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w Maintenance Period (Until PD) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3wType: DrugControl group
Name: Bevacizumab
Description: Bevacizumab(15 mg/kg IV);Over 90 (±15) min (for the first infusion); shortening to 60 (± 10) then 30 (± 10) min for subsequent infusions if toleratedType: DrugAtezolizumab group
Name: Carboplatin
Description: Carboplatin(AUC 6 IV a); Over approximately 15-30 minType: DrugAtezolizumab group
Name: Paclitaxel
Description: Paclitaxel(200 mg/m2 IV); Over 3 hoursType: DrugAtezolizumab group
Name: Carboplatin or cisplatin
Description: Carboplatin(AUC 6 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3wType: DrugControl group
Description: To evaluate the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab as progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECIST v1.1) in the following treatment:Atezolizumab + carboplatin + paclitaxel + bevacizumab versus Pemetrexed + carboplatin or cisplatin
Measure: progression-free survival, PFS Time: through study completion, an average of 1 yearAllocation: Randomized
Parallel Assignment
There is one SNP
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. --- T790M ---