Status:
WITHDRAWN
Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoma
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two pr...
Eligibility Criteria
Inclusion
- Stage IIIB or IV NSCLC (any histology) at the time of study entry
- Histologically or cytologically confirmed diagnosis of NSCLC that is:
- EGFR wt as per patient standard of care by a validated test
- AND ALK-negative rearrangement as part of the patient standard of care by a validated test
- 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 mutations regardless of cMET GCN, or
- Patients must have failed one or two prior lines of 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
- 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
- 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
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03240393
Start Date
July 31 2018
End Date
October 26 2021
Last Update
July 26 2018
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