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Report for Clinical Trial NCT02864251
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      The main purpose of this study is to determine whether nivolumab + chemotherapy is effective
      as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed
      first line (1L) or second-line (2L) EGFR TKI therapy.
    
Name: Nivolumab
Description: Specified dose on specified days
 Type: Biological
Group Labels:  2  Nivolumab + Ipilimumab  Nivolumab+Platinum doublet chemotherapy  
 Name: Ipilimumab
Description: Specified dose on specified days
 Type: Biological
Group Labels:  1  Nivolumab + Ipilimumab  
 Name: Pemetrexed
Description: Specified dose on specified days
 Type: Drug
Group Labels:  2  Nivolumab+Platinum doublet chemotherapy  Platinum doublet chemotherapy  
 Name: Cisplatin
Description: Specified dose on specified days
 Type: Drug
Group Labels:  2  Nivolumab+Platinum doublet chemotherapy  Platinum doublet chemotherapy  
 Name: Carboplatin
Description: Specified dose on specified days
 Type: Drug
Group Labels:  2  Nivolumab+Platinum doublet chemotherapy  Platinum doublet chemotherapy  
  
Primary Outcomes 
 Measure: Progression free survival (PFS) assessed by blinded independent central review (BICR) Time: up to 47 months
   
Secondary Outcomes 
 Measure: Overall survival (OS) Time: Up to 74 months
 Measure: Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST) 1.1 by BICR Time: Up to 47 months
 Measure: Duration of response (DOR) by BICR Time: Up to 47 months
 Measure: Progression free survival (PFS) rate by BICR Time: Up to 47 months
 
Purpose: Treatment
Allocation: Randomized
Parallel Assignment 
There is one SNP
SNPs
1 T790M 
-  No evidence of exon 20 T790M mutation obtained at progression on prior first- or
             second-generation EGFR TKI therapy. --- T790M --- 
For participants who were treated with osimertinib, T790M testing is not
             required. --- T790M --- 
-  Eastern Cooperative Group (ECOG) Performance Status 0-1
          -  Life expectancy is at least 3 months
        Exclusion Criteria:
          -  Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI
             should receive osimertinib first as the standard of care (SOC). --- T790M ---