Status: Active Trial | Marker: MET

Title

A double-blind, Placebo controlled, randomized, Phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and Placebo as first line Treatment for locally advanced or metastatic non-small cell lung Cancer patients with MET exon 14 skipping mutations.

Study Number

NCT04323436

Indication

Histologically or cytologically confirmed and documented stage IIIB, IIIC or IV unresectable, squamous or non-squamous NSCLC which is in Addition:
a) harboring MET exon 14 skipping mutations, as determined by central pre-screening assessment performed at a Novartis designated lab, of not previously determined locally
b) Negative for any mutations that are known to sensitize to EGFR Inhibitors, such as exon19 deletions or L858R Substitution
c) Negative for ALK rearrangements

Primary Objective

Effect of capmatinib in combination with spartalizumab in inducting radiological Response by BIRC as per RECIST 1.1 in first line NSCLC with MET exon 14 skipping Mutation, regardless of study Treatment discontinuatino or start of new anti-neoplastic therapy.

In- and exclusion Criteria

• Histologically or cytologically confirmed and documented stage IIIB, IIIC or IV unresectable, squamous or non-squamous NSCLC harboring MET exon 14 skipping mutation
• Patients must not have received any systemic therapy for advanced/metastatic disease. Neo-adjuvant and adjuvant systemic therapies are permitted if relapse occurred > 12 months from the end of therapy

Study Design

Phase II, multicenter, randomized, two-arm study

Responsibilities

Sponsor 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
E-Mail: lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. Jürgen Wolf

Letzte Änderung: 1. October 2020