SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02468661

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)

The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

NCT02468661 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: INC280 single agent

Type: Drug

INC280 single agent

Name: INC280 in combination with erlotinib

Type: Drug

INC280 in combination with erlotinib

Name: Platinum/pemetrexed

Type: Drug

Platinum in combination with pemetrexed


Primary Outcomes

Measure: Phase Ib: Frequency and characteristics of Dose Limiting Toxicity (DLTs) to the INC280 and erlotinib combination

Time: First 28 days of dosing

Secondary Outcomes

Description: Correlation between IHC determined expression level and PFS

Measure: Phase Ib: Progression Free Survival (PFS)

Time: Every 6 weeks, up to 2 years

Description: OS, defined as time from the first dose of study treatment to death due to any cause

Measure: Phase Ib: Overall Survival (OS)

Time: Every 3 weeks, up to 5 years

Description: Safety and tolerability of INC280 in combination with erlotinib assessed by change in vital signs, laboratory results and electrocardiogram (ECG).

Measure: Phase Ib: Number of patients with adverse events (AEs) as a measure of safety and tolerability

Time: Every 3 weeks, up to 2 years

Description: Composite pharmacokinetics of INC280 in the presence of erlotinib.

Measure: Phase Ib: Plasma concentration-time profiles of INC280 and pharmacokinetic parameters

Time: 6 weeks

Description: Composite pharmacokinetics of erlotinib in the presence of INC280.

Measure: Phase Ib: Plasma concentration-time profiles of erlotinib in the presence of INC280

Time: 6 weeks

Description: DCR, proportion of patients with best overall response of CR, PR or SD

Measure: Phase Ib: Disease Control Rate (DCR)

Time: Every 6 weeks, up to 2 years

Description: DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

Measure: Phase Ib: Duration of Response (DOR)

Time: Every 6 weeks, up to 2 years

Description: PFS, defined as time from the first dose of study treatment to disease progression or death due to any cause

Measure: Phase Ib: Progression-free Survival (PFS)

Time: Every 6 weeks, up to 2 years

Description: Safety and tolerability of INC280 in combination with erlotinib assessed by change in vital signs, laboratory results and electrocardiogram (ECG).

Measure: Phase Ib: Number of patients with serious adverse events as a measure of safety and tolerability

Time: Every 3 weeks, up to 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Safety and tolerability of INC280 in combination with erlotinib assessed by change in vital signs, laboratory results and electrocardiogram (ECG).. Inclusion Criteria: - Locally advanced or metastatic NSCLC - EGFR mutation (L858R and /or ex19del) - cMET amplification by FISH (GCN ≥ 6), - Acquired resistance to EGFR TKI (1st or 2nd génération) - ECOG performance status (PS) ≤ 1. Exclusion Criteria: - Prior treatment with 3rd generation TKI - PhaseII : Prior treatment with any of the following agents: - Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor. --- L858R ---

- Platinum-based chemotherapy as first line treatment Inclusion Criteria: - Locally advanced or metastatic NSCLC - EGFR mutation (L858R and /or ex19del) - cMET amplification by FISH (GCN ≥ 6), - Acquired resistance to EGFR TKI (1st or 2nd génération) - ECOG performance status (PS) ≤ 1. Exclusion Criteria: - Prior treatment with 3rd generation TKI - PhaseII : Prior treatment with any of the following agents: - Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor. --- L858R ---



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