A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non-small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)
- Conditions
- non-small cell lung cancerlung cancer1003866610038716
- Registration Number
- NL-OMON42451
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
* * 18 years of age.
* Stage IIIB or IV NSCLC other than predominantly squamous cell histology, harboring EGFR mutation exon 19 deletion or L858R.
* Acquired resistance to EGFR TKI of the 1st or 2nd generation. See protocol page 15 for details.
* One prior line of treatment is defined as:
o Only one prior line of 1st or 2nd generation EGFR TKI for the treatment of locally advanced or metastatic NSCLC
o No prior chemotherapy is allowed. Exceptions: see protocol page 15 for details.
* Molecular pre-screening assessment:
o cMET-amplification (GCN * 6) on a newly obtained tumor biopsy (preferred) or an archival tumor sample obtained at or any time after the progression on prior 1st or 2nd generation EGFR TKI.
o EGFRT790M negative status assessed from a biopsy or an archival tumor sample collected after the progression on prior 1st or 2nd generation EGFR TKI.
* Presence of at least one measurable lesion. See protocol page 15 for details.
* ECOG performance status 0 or 1.
* Life expectancy at least 3 months.
* Prior treatment with crizotinib, or any other cMET or HGF inhibitor, concomitant EGFR TKI and platinum based chemotherapy or platinum-based as first line regimen.
* Prior treatment with any 3rd generation EGFR TKI.
* Symptomatic CNS metastases.
* Presence or history of interstitial lung disease or interstitial pneumonitis.
* Presence of clinically significant ophthalmologic abnormalities.
* Clinically significant, uncontrolled heart diseases. See protocol page 44 for details.
* Strong inhibitors of CYP3A4, moderate and strong inducers of CYP3A4, strong inhibitors or inducers of CYP1A2, proton pump inhibitors within 1 week prior to the start of INC280 and during treatment.
* Pregnancy, lactation, insufficient contraception for females of childbearing potential.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I: MTD and/or RP2D<br /><br><br /><br>Phase II: PFS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase I: MTD and/or RP2D DOR, ORR, DCR, PFS, adverse events, PK parameters.<br /><br><br /><br><br /><br>Phase II: DOR, ORR, DCR, PFS, OS, adverse events, PK parameters.</p><br>