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A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

NCT02468661

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

A Safety and Efficacy Study of INC280 Alone, and in Combination With <span class="go-doc-concept go-doc-intervention">Erlotinib</span>, Compared to <span class="go-doc-concept go-doc-intervention">Chemotherapy</span>, in Advanced/Metastatic Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Patients With <span class="go-doc-concept go-doc-biomarker">EGFR</span> <span class="go-doc-concept go-doc-keyword">Mutation</span> and <span class="go-doc-concept go-doc-biomarker">cMET</span> <span class="go-doc-concept go-doc-keyword">Amplification</span>

Title

  • Brief Title: A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
  • Official Title: 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)
  • Clinical Trial IDs

    NCT ID: NCT02468661

    ORG ID: CINC280B2201

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    INC280 single agent INC280 single agent
    INC280 in combination with erlotinib INC280 in combination with erlotinib
    Platinum/pemetrexed Platinum in combination with pemetrexed

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    INC280 single agent Experimental INC280 single agent
    INC280 in combination with erlotinib Experimental INC280 in combination with erlotinib
    Platinum in combination with pemetrexed Active Comparator Platinum (cisplatin or carboplatin) in combination with pemetrexed Platinum/pemetrexed

    Eligibility Criteria

    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 gnration)

    - 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.

    - Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.

    - Platinum-based chemotherapy as first line treatment

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

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

    Phase II: Progression-free Survival (PFS)

    Secondary Outcome Measures

    Phase Ib: Overall Response Rate (ORR)

    Phase Ib: Overall Survival (OS)

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

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

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

    Phase II: Overall Response Rate (ORR) by investigator's assessment according to RECIST v1.1

    Phase II: Overall Survival (OS)

    Phase II: Number of patients with AEs/serious adverse events (SAEs) as a measure of safety and tolerability (INC280 + erlotinib)

    Phase II: Number of patients with AEs/SAEs as a measure of safety and tolerability (INC280 alone)

    Phase II: Plasma concentration of INC280 (INC280 + erlotinib)

    Phase II: Phase II: Plasma concentration of INC280 (INC280 alone)

    Phase II: Plama concentrations of INC280 (erlotinib + INC280)

    Phase Ib: Disease Control Rate (DCR)

    Phase Ib: Duration of Response (DOR)

    Phase Ib: Progression-free Survival (PFS)

    Phase II: Disease Control Rate (DCR) by investigator's assessment according to RECIST v1.1

    Phase II: Duration of Response (DOR) by investigator's assessment according to RECIST v1.1

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

    Phase II: Overall Response Rate (ORR), Disease Control Rate by investigator's assessment according to RECIST v1.1

    Trial Keywords

    Non-Small Cell Lung Cancer