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Report for Clinical Trial NCT03215706

Developed by Shray Alag, 2020.
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
Group Labels: 1

Module A

Name: Nivolumab

Description: Specified dose on specified day
Type: Biological
Group Labels: 1

Module A

Name: Carboplatin

Description: Specified dose on specified day
Type: Drug
Group Labels: 2

Module A Module B

Name: Paclitaxel

Description: Specified dose on specified day
Type: Drug
Group Labels: 2

Module A Module B

Name: Pemetrexed

Description: Specified dose on specified day
Type: Drug
Group Labels: 2

Module A Module B

Name: Cisplatin

Description: Specified dose on specified day
Type: Drug
Group Labels: 2

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: