Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

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%

ClinicalTrials.gov Identifier: NCT04139317

Novartis Reference Number: CINC280I12201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

Condition 
Non-small Cell Lung Cancer (NSCLC)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
96 participants
Start date 
Jan 22, 2020
Completion date 
Mar 28, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Capmatinib
Oral tablet
Biological
Pembrolizumab
IV infusion

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)
ECOG performance status score ≤ 1
Have at least 1 measurable lesion by RECIST 1.1
Have adequate organ function

Exclusion Criteria:

Prior treatment with a MET inhibitor or HGF-targeting therapy
Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
Have untreated symptomatic central nervous system (CNS) metastases
Clinically significant, uncontrolled heart diseases
Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Sarah Cannon Research Institute
Recruiting
Nashville, 37203
Tennessee
United States
Australia
Novartis Investigative Site
Recruiting
Wollongong, 2500
New South Wales
Australia
Novartis Investigative Site
Recruiting
Shepparton, 3630
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1000
-
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Novartis Investigative Site
Recruiting
Yvoir, 5530
-
Belgium
Czechia
Novartis Investigative Site
Recruiting
Ostrava Vitkovice, 703 84
-
Czechia
France
Novartis Investigative Site
Recruiting
LILLE Cédex, 59037
-
France
Novartis Investigative Site
Recruiting
Strasbourg Cedex, 67091
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex 9, 31059
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 14165
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Hong Kong
Novartis Investigative Site
Recruiting
Shatin, New Territories,
-
Hong Kong
India
Novartis Investigative Site
Recruiting
Kolkata, 700160
West Bengal
India
Novartis Investigative Site
Recruiting
Delhi, 110 085
-
India
Italy
Novartis Investigative Site
Recruiting
Ancona, 60126
AN
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236 0051
Kanagawa
Japan
Malaysia
Novartis Investigative Site
Recruiting
Kuching, 93586
Sarawak
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 59100
-
Malaysia
Spain
Novartis Investigative Site
Recruiting
Badalona, 08916
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08025
Cataluña
Spain
Novartis Investigative Site
Recruiting
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Changhua, 50006
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10330
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]