SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03256136

Developed by Shray Alag, 2019.
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 with EGFR Chemo naive Nivolumab + Carboplatin + Pemetrexed ALK Chemo naive

Name: Nivolumab

Description: will allow the body's immune system to work against tumor cells

Type: Drug

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

Name: pemetrexed

Description: Chemo therapy

Type: Drug

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

Name: Ipilimumab

Description: will allow the body's immune system to work against tumor cells

Type: Drug

Nivolumab Plus Ipilimumab EGFR Nivolumab Plus Ipilimumab ALK


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 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