A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)
NSCLC harbouring MET mutation in second line treatment
The primary objective is to demonstrate the antitumor activity of INC280, as measured by overall response rate (ORR) to INC280 by Blinded Independent Review Committee (BIRC) assessment, by cohort.
In- and exclusion Criteria
- Stage IIIB or IV NSCLC (any histology) at the time of study entry
- Histologically or cytologically confirmed diagnosis of NSCLC that is:
- EGFR wt. This should have been assessed as part of the patient standard of care by a validated test for EGFR mutations, as per the Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors from College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology (Lindeman et al 2013). The EGFR wt status (for exon 19 deletions and exon 21 L858R substitution mutations) must be documented in the patient source documents before the patient can be consented for pre-screening for cMET amplification and cMET mutation status. Patients with NSCLC of pure squamous cell histology can enter pre-screening without EGFR mutation testing or result, however patients with pure squamous cell
- AND ALK-negative rearrangement. This should have been assessed as part of the patient standard of care by a validated test. The ALK rearrangement negative status must be documented in the patient source documents before the patient can be consented for pre-screening for cMET amplification and cMET mutation status; if local ALK testing is not available, patient status will be determined centrally along with the cMET status. Patients with NSCLC of pure squamous cell histology can enter pre-screening without ALK testing or result, however patients with pure squamous cell histology that are known to have ALK rearrangement will be excluded.
- Prior treatment with crizotinib, or any other cMET or HGF inhibitor
- Patients with known hypersensitivity to any of the excipients of INC280 (crospovidone, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide, and various coating premixes).
- 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.
Sponsor Novartis Pharma GmbH
Phone: +49 - 911 2730
Fax: +49 -0911 27312683
University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
Prof. Dr. J. Wolf
Last Update: 17. July 2017