SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03215706

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

NCT03215706 Non-Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

6 Interventions

Name: Ipilimumab

Description: Specified dose on specified day

Type: Biological

Module A

Name: Nivolumab

Description: Specified dose on specified day

Type: Biological

Module A

Name: Carboplatin

Description: Specified dose on specified day

Type: Drug

Module A Module B

Name: Paclitaxel

Description: Specified dose on specified day

Type: Drug

Module A Module B

Name: Pemetrexed

Description: Specified dose on specified day

Type: Drug

Module A Module B

Name: Cisplatin

Description: Specified dose on specified day

Type: Drug

Module A Module B


Primary Outcomes

Description: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy

Measure: Overall Survival (OS)

Time: Up to 31 months

Secondary Outcomes

Description: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy

Measure: Progression Free Survival (PFS)

Time: Up to 31 months

Description: To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy

Measure: Overall Response Rate (ORR)

Time: Up to 31 months

Description: In participants with different PD-L1 levels

Measure: ORR

Time: Up to 31 months

Description: In participants with different PD-L1 levels

Measure: PFS

Time: Up to 31 months

Description: In participants with different PD-L1 levels

Measure: OS

Time: Up to 31 months

Measure: ORR, PFS, OS: In association with tumor mutation numbers

Time: Up to 31 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 - Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria - Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period Exclusion Criteria: - Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded - Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded - Participants with untreated CNS metastases are excluded. --- L858R ---



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