A Phase IB/II, open label, multicenter study of INC280 administered orally in combination with gefitinib in adult patients with EGFR mutated, c-MET-amplified non-small cell lung cancer who have progressed after EGFR inhibitor treatment (CINC280X2202)
- Conditions
- non-small cell lung cancerlung cancer10038666
- Registration Number
- NL-OMON41765
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
* * 18 years of age.
* Confirmed c-MET pathway dysregulation (see protocol page 35-36 for details).
* EGFR mutated NSCLC patient who have developed acquired resistance to EGFR inhibitor treatment (see protocol page 35 for details).
* Must have discontinued any previous anti-cancer and investigational therapy (excluding gefitinib or erlotinib) for at least 28 days before study treatment administration.
* No more than 2 lines of chemotherapy and one line of gefitinib or erlotinib treatment.
* Must have discontinued any previous anti-cancer antibody treatment for at least 4 weeks before study treatment administration.
* Measurable disease as determined by RECIST version 1.1.
* ECOG performance status *2.
* Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
* Previous radiation therapy completed less than 4 weeks prior to dosing.
* History of cystic fibrosis.
* History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase the risk of pancreatitis.
* Pregnancy, breast feeding.
* Women of child-bearing potential not willing to use highly effective contraception.
* Sexually active males must use a condom during intercourse and should not father a child in the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose-escalation: DLTs in 1st cycle.<br /><br>Expansion: AEs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Tumor response assessment as per RECIST v1.1. PK. Biomarkers in tumor tissue.</p><br>