Status: Active Trial | Marker: no marker

Title

A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adult patients with EGFR wild-type, ALK rearrangement negative locally advanced/metastatic non-small cell lung cancer.

Study Number
NCT03647488
Indication

• Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC
• EGFR Wildtype
• ALK negative

Primary objective

Part 1: Run-in
• To assess safety and tolerability of capmatinib and spartalizumab combination in subjects with NSCLC, who have received one or more prior lines of systemic therapy for the locally advanced/metastatic stage of disease and are potential candidates for docetaxel single agent chemotherapy

Part 2: Randomized
• To assess the overall survival of combination of capmatinib and spartalizumab in comparison to docetaxel

In- and exclusion Criteria

• Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC
• Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wt
status and ALK- negative rearrangement status: Patients with NSCLC of pure squamous cell histology can enter screening without EGFR mutation or ALK rearrangement testing or result; however, patients with pure squamous cell histology who are known to have EGFR mutations in exons 19 or 21 or ALK rearrangements will be excluded

Study design
Phase II, multicenter, randomized, two-arm study
Responsibilities

Novartis Pharma GmbH
Tel. +49 911 2730
Fax: +49 911 27312683

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. J. Wolf

Last Update: 14. February 2019