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Report for Clinical Trial NCT02864251

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

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.

NCT02864251 Non-Small-Cell Lung Carcinoma
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

5 Interventions

Name: Nivolumab

Type: Biological
Group Labels: 2

Nivolumab + Ipilimumab Nivolumab+Platinum doublet chemotherapy

Name: Ipilimumab

Type: Biological
Group Labels: 1

Nivolumab + Ipilimumab

Name: Pemetrexed

Type: Drug
Group Labels: 2

Nivolumab+Platinum doublet chemotherapy Platinum doublet chemotherapy

Name: Cisplatin

Type: Drug
Group Labels: 2

Nivolumab+Platinum doublet chemotherapy Platinum doublet chemotherapy

Name: Carboplatin

Type: Drug
Group Labels: 2

Nivolumab+Platinum doublet chemotherapy Platinum doublet chemotherapy


Primary Outcomes

Measure: Progression free survival (PFS) in participants with epidermal growth factor receptor (EGFR) mutation positive non-small cell lung carcinoma (NSCLC)

Time: up to 47 months

Secondary Outcomes

Measure: Overall survival (OS)

Time: Up to 74 months

Measure: Objective response rate (ORR)

Time: Up to 47 months

Measure: Duration of response (DOR)

Time: Up to 47 months

Measure: Progression free survival (PFS) rate

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 subjects 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: - Subjects with known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). --- T790M ---



HPO Nodes


HPO: