SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02864251

Developed by Shray Alag, 2019.
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: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

5 Interventions

Name: Nivolumab

Type: Biological

Nivolumab+Platinum doublet chemotherapy Nivolumab + Ipilimumab

Name: Ipilimumab

Type: Biological

Nivolumab + Ipilimumab

Name: Pemetrexed

Type: Drug

Nivolumab+Platinum doublet chemotherapy Platinum doublet chemotherapy

Name: Cisplatin

Type: Drug

Nivolumab+Platinum doublet chemotherapy Platinum doublet chemotherapy

Name: Carboplatin

Type: Drug

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:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1