Clinical Research Details

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Descriptive Information
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.

Arafat Tfayli
at35@aub.edu.lb

CINC280A2201
Recruiting

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 2  

No
Sponsors
  • Novartis
Conditions and Keywords
Lung cancer
NSCLC, cMET inhibitor, INC280
Study Design
Eligibility and IRB
Both
Min: 18
Max:
Yes
No

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.



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: Pre-treated patients with cMET GCN ≥ 6 or
      • Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
      • Cohort 3: Pre-treated patients with cMET GCN < 4, or
      • Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
      • Cohort 5: Treatment-naïve patients with cMET dysregulation
  • To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  • To be eligible for Cohort 5, patients must not have received any systemic therapy for advanced/metastatic disease
  • 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
  • Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  • Patients receiving treatment with any enzyme-inducing anticonvulsant
  • Applicable to Cohorts 1-4 only: Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  • 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

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