A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1* 50%

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

* Males or females * 18 years of age.
* Histologically confirmed locally advanced stage III (not candidates for
surgical resection or definitive chemo-radiation) or stage IV (metastatic)
NSCLC for treatment in the first-line setting. See protocol chapter 5.1 item 3
for further details.
* Both EGFR wild type status and ALK-negative rearrangement status. See
protocol chapter 5.1 item 4 for further details.
* Archival tumor sample or newly obtained tumor biopsy with high PD-L1
expression (TPS * 50%) at screening. See protocol chapter 5.1 item 5 for
further details.
* ECOG performance status of 0 or 1.
* At least one measurable lesion. See protocol chapter 5.1 item 7 for further
details.
* Adequate organ function. See protocol paragraph 5.1 item 9 for details

Exclusion Criteria

* Prior treatment with a MET inhibitor or HGF-targeting therapy.
* Prior immunotherapy. See protocol paragraph 5.2 item 2 for details.
* History of severe hypersensitivity reactions to other monoclonal antibodies.
* Untreated symptomatic CNS metastases, see protocol paragraph 5.2 item 5 for
details.
* Presence or history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis (i.e. affecting
activities of daily living or requiring therapeutic intervention).
* Clinically significant, uncontrolled heart disease, see protocol paragraph
5.2, item 8.
* Concomitant medication(s) with a *Known Risk of Torsades de Point (TdP)* per
www.qtdrugs.org that cannot be discontinued or replaced.
* Treatment with strong inducers of CYP3A4 that cannot be discontinued at least
1 week prior to the start of treatment with capmatinib and for the duration of
the study.
* Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any
immunosuppressive therapy 7 days prior to planned date of first dose of study
treatment, see protocol paragraph 5.2 item 14 for details.
* Live vaccination within 4 weeks prior to first dose of study drug.
* Active, known or suspected autoimmune disease or documented history, see
protocol paragraph 5.2 item 20 for details.
* Pregnant or lactating women, females of childbearing potential not using
adequate contraception and males not using adequate contraception. See protocol
paragraph 5.2 item 22-24 for details.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression-free survival (PFS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective response rate (ORR), disease control rate (DCR), time-to-response<br /><br>(TTR) and duration of response (DOR) and overall survival (OS), adverse events,<br /><br>pharmacokinetic parameters, antidrug antibodies against pembrolizumab.</p><br>