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Report for Clinical Trial NCT02468661

Developed by Shray Alag, 2020.
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 was 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

2 Interventions

Name: INC280 single agent

Type: Drug
Group Labels: 2

INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD

Name: erlotinib

Type: Drug
Group Labels: 2

INC280 200mg BID + ERL 150mg QD INC280 400mg BID + ERL 150mg QD


Primary Outcomes

Description: To determine MTD and/or RP2D of INC280 in combination with erlotinib

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: ORR, proportion of patients with a best overall response of complete response or partial Response (CR+PR)

Measure: Phase Ib: Overall response rate (ORR)

Time: Every 3 weeks, up to 5 years

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 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

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Composite pharmacokinetics of erlotinib in the presence of INC280.. 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 generation) - 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 generation) - 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


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