SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02323126

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II, Multicenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients With cMet Positive Non-small Cell Lung Cancer

To determine the efficacy and safety of Nivolumab in combination with EGF816 and of Nivolumab in combination with INC280 in previously treated NSCLC patients

NCT02323126 Non Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: EGF816

Type: Drug

Nivolumab and EGF816

Name: INC280

Type: Drug

Nivolumab and INC280

Name: Nivolumab

Type: Drug

Nivolumab and EGF816 Nivolumab and INC280


Primary Outcomes

Measure: Progression Free Survival (PFS) rate using RECIST version1.1

Time: 6 month

Secondary Outcomes

Description: Safety of EGF816 and Nivolumab and INC280 and Nivolumab by looking at hematology and chemistry laboratory parameters, vital signs, and electrocardiograms (ECGs)

Measure: Number of participants with Adverse Events (AEs)

Time: Continuously during study until 100 days after post study treatment

Measure: Objective response rate (ORR)

Time: baseline, every 8 weeks up to cycle 12, then every 12 weeks from cycle 13 until disease progression, consent withdrawal or death up to 1 year

Measure: Disease control rate

Time: baseline, every 8 weeks upto cycle 12, then every 12 weeks from cycle 13 until disease progression, consent withdrawal or death up to 1 year

Measure: Progression free survival

Time: baseline, every 8 weeks upto cycle 12, then every 12 weeks from cycle 13 until disease progression, consent withdrawal or death up to 1 year

Measure: Overall Survival

Time: Start of treatment until death, average 1 year

Measure: Plasma pharmacokinetic parameters (AUClast, AUC0-t,AUCtau,Cmax, Tmax)

Time: Cycle 1: Day1, Day 8, Day 15 and Cycle 2: Day 1, Cycle 4: Day 1 Cycle 6: Day 1 and Cycle 8: Day 1 Subsequent cycles (nivolumab only): every 8th cycle until discontinuation of study treatment

Purpose: Treatment

Parallel Assignment


There is one SNP

SNPs


1 T790M

EGFR T790M positivity post progression on EGFR TKI for Group 1; cMet status for Group 2) must be provided for analysis Group 1 patients: - Patients with EGFR T790M NSCLC (adenocarcinoma) - Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. --- T790M ---

EGFR T790M positivity post progression on EGFR TKI for Group 1; cMet status for Group 2) must be provided for analysis Group 1 patients: - Patients with EGFR T790M NSCLC (adenocarcinoma) - Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. --- T790M --- --- T790M ---

Inhaled or topical steroids, and adrenal replacement steroid doses> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection - Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity - Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity Prior therapy: - Patients who have been treated with prior PD-1 and PD-L1 agents - Patients who previously received agents targeting c-MET and/or EGFR T790M Note: Previous treatment with afatinib may be allowable after discussions between Novartis and Investigator. --- 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
Non-small cell lung carcinoma
Genes 2
TP53 BAP1