Study Stopped
Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm
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%
2 other identifiers
interventional
76
16 countries
36
Brief Summary
The purpose was 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedStudy Start
First participant enrolled
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedResults Posted
Study results publicly available
February 8, 2024
CompletedOctober 9, 2024
October 1, 2024
2 years
October 14, 2019
January 15, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm). Due to the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm, PFS was censored on the 21-Jan-2021 or the last adequate tumor assessment prior to that date for the capmatinib plus pembrolizumab arm. PFS was analyzed using Kaplan-Meier estimates.
Up to 1.3 years
Secondary Outcomes (11)
Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1
Up to 1.3 years
Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1
Up to 1.3 years
Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1
Up to 1.3 years
Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1
Up to 1.3 years
Overall Survival (OS)
Up to 2.1 years
- +6 more secondary outcomes
Study Arms (2)
Capmatinib 400mg BID + pembrolizumab 200mg Q3W
EXPERIMENTALCapmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)
Pembrolizumab 200mg Q3W
ACTIVE COMPARATORPembrolizumab 200 mg intravenously every 3 weeks (Q3W)
Interventions
INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle.
Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Novartis Investigative Site
Wollongong, New South Wales, 2500, Australia
Novartis Investigative Site
North Adelaide, South Australia, 5006, Australia
Novartis Investigative Site
Shepparton, Victoria, 3630, Australia
Novartis Investigative Site
Yvoir, 5530, Belgium
Novartis Investigative Site
Québec, Quebec, GIV 4G5, Canada
Novartis Investigative Site
Ostrava Vitkovice, 703 84, Czechia
Novartis Investigative Site
Lille, 59000, France
Novartis Investigative Site
Strasbourg, 67091, France
Novartis Investigative Site
Toulouse, 31400, France
Novartis Investigative Site
Berlin, 14165, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Athens, 11526, Greece
Novartis Investigative Site
Thessaloniki, 57001, Greece
Novartis Investigative Site
Shatin New Territories, Hong Kong, Hong Kong
Novartis Investigative Site
Mumbai, Maharashtra, 401107, India
Novartis Investigative Site
Kolkata, West Bengal, 700160, India
Novartis Investigative Site
Delhi, 110 085, India
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Aviano, PN, 33081, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, 466 8560, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 236 0051, Japan
Novartis Investigative Site
Kuching, Sarawak, 93586, Malaysia
Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site
Amersfoort, 3813 TZ, Netherlands
Novartis Investigative Site
Breda, 4819 EV, Netherlands
Novartis Investigative Site
Zwolle, 8025 AB, Netherlands
Novartis Investigative Site
Badalona, Catalonia, 08916, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Valencia, Valencia, 46010, Spain
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Changhua, 50006, Taiwan
Novartis Investigative Site
Taichung, 40705, Taiwan
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 25, 2019
Study Start
January 22, 2020
Primary Completion
January 14, 2022
Study Completion
February 7, 2023
Last Updated
October 9, 2024
Results First Posted
February 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.