SNPMiner Trials (Home Page)
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 ---