Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT03240393
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: 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 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03240393
Study Brief:
Protocol Section:
NCT03240393