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Report for Clinical Trial NCT03991403
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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 PD
 Type: Drug
Group Labels:  1  Atezolizumab 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 q3w
 Type: Drug
Group Labels:  1  Control 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 tolerated
 Type: Drug
Group Labels:  1  Atezolizumab group  
 Name: Carboplatin
Description: Carboplatin(AUC 5 or 5.5 IV a); Over approximately 15-30 min
 Type: Drug
Group Labels:  1  Atezolizumab group  
 Name: Paclitaxel
Description: Paclitaxel(175 mg/m2 IV); Over 3 hours
 Type: Drug
Group Labels:  1  Atezolizumab group  
 Name: Carboplatin or cisplatin
Description: Carboplatin(AUC 5.5 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3w
 Type: Drug
Group Labels:  1  Control group  
  Primary Outcomes 
 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 year
    
Secondary Outcomes 
 Measure: overall survival(OS) Time: through study completion, an average of 1 year
 Measure: objective response rate(ORR) Time: through study completion, an average of 1 year
 Measure: duration of response(DOR) Time: through study completion, an average of 1 year
 
Purpose: Treatment
Allocation: Randomized
Parallel Assignment 
There is one SNP
SNPs
1 T790M 
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 ---