Clinical Trials /

Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer

NCT02414139

Description:

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Clinical Study of Oral <span class="go-doc-concept go-doc-biomarker">cMET</span> Inhibitor INC280 in Adult Patients With Advanced Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Who Have Received One or Two Prior Lines of Therapy

Title

  • Brief Title: Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With Advanced Non-small Cell Lung Cancer Who Have Received One or Two Prior Lines of Therapy
  • Official Title: A Phase II, Multicenter, Three-cohort Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Received One or Two Prior Lines of Systemic Therapy for Advanced/Metastatic Disease
  • Clinical Trial IDs

    NCT ID: NCT02414139

    ORG ID: CINC280A2201

    NCI ID: 2014-003850-15

    Trial Conditions

    Carcinoma, Non-Small-Cell Lung

    Trial Interventions

    Drug Synonyms Arms
    INC280 (capmatinib) cMET GCN 6, cMET GCN 4 and < 6, cMET GCN < 4

    Trial Purpose

    A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult
    patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) after one or two
    prior lines of systemic therapy for advanced/metastatic disease as measured by overall
    response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    cMET GCN 6 Experimental Patients with cMET GCN 6 treated with INC280 at 400mg BID INC280 (capmatinib)
    cMET GCN 4 and < 6 Experimental Patients with cMET GCN 4 and < 6 treated with INC280 at 400 mgBID INC280 (capmatinib)
    cMET GCN < 4 Experimental Patients with cMET GCN < 4 treated with INC280 at 400mg BID INC280 (capmatinib)

    Eligibility Criteria

    Inclusion Criteria:

    - Stage IIIB or IV NSCLC (any histology) at the time of study entry

    - Histologically or cytologically confirmed diagnosis of NSCLC that is:

    1. EGFR wt as per patient standard of care by a validated test

    2. AND ALK-negative rearrangement as part of the patient standard of care by a
    validated test

    3. AND (by central assessment) either:

    - Cohort 1: cMET GCN 6, or

    - Cohort 2: cMET GCN 4 and < 6, or

    - Cohort 3: cMET GCN < 4

    - Patients must have received one or two prior lines of systemic therapy

    - At least one measurable lesion as defined by RECIST 1.1.

    - Patients must have recovered from all toxicities related to prior anticancer
    therapies to grade 1 (CTCAE v 4.03). Patients with any grade of alopecia are
    allowed to enter the study.

    - Patients must have adequate organ function

    - ECOG performance status (PS) of 0 or 1. Details and other protocol-defined inclusion
    criteria may apply

    Exclusion Criteria:

    - Prior treatment with crizotinib, or any other cMET or HGF inhibitor

    - Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy,
    including, but not limited to exon 19 deletions and exon 21 mutations.

    - Patients with characterized ALK-positive rearrangement.

    - Clinically significant, uncontrolled heart diseases.

    - Patients receiving treatment with medications that cannot be discontinued at least 1
    week prior to first INC280 treatment and for the duration of the study:

    - Strong and moderate inhibitors of CYP3A4

    - Strong inducers of CYP3A4

    - Proton pump inhibitors (PPI)

    - Impairment of GI function or GI disease that may significantly alter the absorption
    of INC280

    - Patients receiving treatment with any enzyme-inducing anticonvulsant.

    - Previous anti-cancer and investigational agents.

    - Pregnant or nursing women

    - Women of child-bearing potential, unless they are using highly effective methods of
    contraception

    - Sexually active males unless they use a condom during intercourse

    Other protocol-defined exclusion criteria may apply

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Response Rate (ORR)

    Secondary Outcome Measures

    Duration of Response (DOR) - Key Secondary

    Overall Response Rate (ORR)

    Duration of Response (DOR)

    Time to Response (TTR)

    Disease Control Rate (DCR)

    Progression-free Survival (PFS)

    Overall Survival (OS)

    Number of patients with incidence of adverse events and serious adverse events, change in vital signs, laboratory results (hematology, blood chemistry, and urinalysis) and ECG.

    Cmax, Cmin and plasma concentration-time profiles of INC280

    Trial Keywords

    Non Small Cell Lung

    cMET