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Report for Clinical Trial NCT03256136

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Nivolumab in Combination With Carboplatin and Pemetrexed, or Nivolumab in Combination With Ipilimumab, in Patients With Advanced, EGFR-mutant or ALK-rearranged, Non-Small Cell Lung Cancer

This research study is studying a drug intervention as a possible treatment for lung cancer. The drugs involved in this study are: - Nivolumab - Carboplatin - Pemetrexed - Ipilimumab

NCT03256136 Lung Cancer
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

4 Interventions

Name: Carboplatin

Description: Chemotherapy
Type: Drug
Group Labels: 2

Nivolumab + Carboplatin + Pemetrexed ALK Chemo naive Nivolumab + Carboplatin + Pemetrexed with EGFR Chemo naive

Name: Nivolumab

Description: will allow the body's immune system to work against tumor cells
Type: Drug
Group Labels: 4

Nivolumab + Carboplatin + Pemetrexed ALK Chemo naive Nivolumab + Carboplatin + Pemetrexed with EGFR Chemo naive Nivolumab Plus Ipilimumab ALK Nivolumab Plus Ipilimumab EGFR

Name: pemetrexed

Description: Chemo therapy
Type: Drug
Group Labels: 2

Nivolumab + Carboplatin + Pemetrexed ALK Chemo naive Nivolumab + Carboplatin + Pemetrexed with EGFR Chemo naive

Name: Ipilimumab

Description: will allow the body's immune system to work against tumor cells
Type: Drug
Group Labels: 2

Nivolumab Plus Ipilimumab ALK Nivolumab Plus Ipilimumab EGFR


Primary Outcomes

Description: Complete response (CR) or partial response (PR) per RECIST version 1.1

Measure: Objective Response Rate (ORR)

Time: 2 years

Secondary Outcomes

Description: Complete response (CR), partial response (PR), or stable disease (SD) per RECIST version 1.1

Measure: Disease Control Rate (DCR)

Time: 2 years

Description: Time from initiation of the study drugs to progression or death, whichever occurs first

Measure: Progression Free Survival (PFS)

Time: 2 years

Description: Time from initiation of the study drugs to date of death due to any cause

Measure: Overall Survival (OS)

Time: 2 years

Description: Time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first

Measure: Duration Of Response

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

- EGFR-mutant NSCLC: EGFR activating gene mutation (e.g., L858R, exon 19 deletion) as well as a T790M mutation per local testing. --- L858R ---


2 T790M

- EGFR-mutant NSCLC: EGFR activating gene mutation (e.g., L858R, exon 19 deletion) as well as a T790M mutation per local testing. --- L858R --- --- T790M ---

- EGFR-mutant NSCLC (cohorts A and C): Participants must have progressed on or after 1 or more third-generation, T790M mutant-selective EGFR-TKI(s). --- T790M ---



HPO Nodes


HPO: