Phase II Multicenter 3-cohort Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Received 1 or 2 Prior Lines of Systemic Therapy for Advanced/Metastatic Disease
| Registry | NCT03240393 |
|---|---|
| Status | Withdrawn - Company Decision |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Sponsor | Novartis Pharmaceuticals (Industry) |
| Conditions | Carcinoma, Non-Small-Cell Lung Cancer |
| Interventions | INC280 (Drug) |
| Dates | start 2018-07-31 (estimated), primary completion 2021-10-26 (estimated), completion 2021-10-26 (estimated), first posted 2017-08-07, last updated 2018-07-26 |
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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 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| cMET GCN ≥ 6 | Experimental | Drug: INC280 | Pre-treated patients with cMET GCN ≥ 6 treated with INC280 at 400mg BID |
| cMET GCN ≥ 4 and < 6 | Experimental | Drug: INC280 | Pre-treated patients with cMET GCN ≥ 4 and < 6 treated with INC280 at 400 mgBID |
| cMET mutations | Experimental | Drug: INC280 | Pre-treated patients with cMET mutations regardless of cMET GCN treated with INC280 at 400mg BID |
Sex: All, ages: 18 Years to any
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