A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)
- Conditions
- non-small cell lung cancer (NSCLC)lung cancer1000628810029107
- Registration Number
- NL-OMON44688
- Lead Sponsor
- ovartis Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
* Female and male patients * 18 years of age.
* Advanced metastatic and/or unresectable NSCLC.
* Measurable disease.
* Group 1: confirmed T790M EGFR mutation.
* Group 2: confirmed c-MET positive.
* ECOG performance status 0, 1, 2.
* Group 1: More than one prior line of EGFR TKI therapy.
* Group 2: Previous treatment with a c-MET inhibitor or HGFtargeting therapy.
* Prior treatment with PD1/PD-L1 targeting therapies.
* Patients who require emergent use of systemic steroids, emergent surgery and/or radiotherapy.
* Interstitial lung disease.
* Any active or history of autoimmune disease, hepatitis B virus or hepatitis C virus
* Prohibited co-medication: see protocol page 46.
* Pregnancy, lactation, inadequate contraception (males and females). See protocol page 30-31 for details.
* Group 2: GI impariment resulting in altered absorption of INC280
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival 6 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other progression free survivals, overall response rate, disease control rate<br /><br>and overall survival. Adverse events. </p><br>