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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

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

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

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

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:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8