A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced nonsmall cell lung cancer (NSCLC) (CINC280A2201)
- Conditions
- lung cancernon-small cell lung cancer1003866610029107
- Registration Number
- NL-OMON54800
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
• Female and male patients >= 18 years of age.
• Stage IIIB or IV NSCLC.
• Histologically or cytologically confirmed diagnosis of NSCLC (see protocol
page 42 for details):
• EGFR wild-type.
• ALK-negative rearrangement.
• Pre-treated Patients with cMET GCN>=6 and <10 (cohort 1a), Patients with cMET
GCN>=10 (cohort 1b), GCN>=4 and <6 (cohort 2), GCN<4 (cohort 3), cMET mutations
(cohort 4). Treatment naive patients with cMET GCN >= 10 (cohort 5a), cMET
mutations (cohort 5b), Pre-treated patients (1 treatment line) with either cMET
GCN >= 10 without cMET mutations or cMET mutations regardless of cMET GCN
(cohort 6 = expansion group). Treatment naive patients with cMET mutations,
regardless of cMET GCN (Cohort 7 = expansion group)
• For cohort 1-4 patients must have received one or two prior lines of systemic
therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). For cohort 5
patients must have received no prior lines of systemic therapy for
advanced/metastatic disease (stage IIIB or IV NSCLC). See protocol page 42 for
details.
• Measurable disease. See protocol page 42 for details.
• ECOG performance status 0-1.
• Prior treatment with crizotinib, or any other cMET or HGF inhibitor.
• Characterized EGFR mutations that predict sensitivity to EGFR therapy.
• Characterized ALK-positive rearrangement.
• Symptomatic CNS metastases who are neurologically unstable or have required
increasing doses of steroids within the 2 weeks prior to study entry.
• Clinically significant, uncontrolled heart diseases. See protocol page 44 for
details.
• Thoracic radiotherapy to lung fields <= 4 weeks prior to starting INC280. For
all other anatomic sites, radiotherapy <= 2 weeks prior to starting INC280.
Palliative radiotherapy for bone lesions <= 2 weeks prior to starting INC280 is
allowed. See protocol page 44 for details.
• Major surgery within 4 weeks prior to starting INC280. See protocol page 44
for details.
• Strong and moderate inhibitors of CYP3A4, strong inducers of CYP3A4, proton
pump inhibitors.
• Unstable or increasing doses of corticosteroids, enzyme-inducing
anticonvulsant. See protocol page 45 for details)
• Pregnancy, lactation, insufficient contraception for females of childbearing
potential.
• Sexually active males unless they use a condom during intercourse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ORR by blinded independent review committee.</p><br>
- Secondary Outcome Measures
Name Time Method <p>DOR, ORR and DOR by investigator, TTR, DCTR, PFS, OS, adverse events, PK<br /><br>parameters.</p><br>