Study Stopped
Study termination based on sponsor decision due to lack of tolerability observed with capmatinib and spartalizumab combination treatment when compared to data from capmatinib single agent studies
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
A Double-blind, Placebo Controlled, Randomized, Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations
2 other identifiers
interventional
31
9 countries
15
Brief Summary
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 (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2020
15 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
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2023
CompletedResults Posted
Study results publicly available
February 6, 2024
CompletedOctober 9, 2024
October 1, 2024
2.3 years
March 23, 2020
November 30, 2023
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Run-in Part: Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1
Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 2 years and 4 months
Randomized Part: Progression-Free Survival (PFS) by BIRC as Per RECIST 1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Tumor response based on blinded independent review committee (BIRC) assessment per RECIST v1.1.
Up to 6 years
Secondary Outcomes (32)
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib
From first dose of capmatinib to last dose, up to 2.4 years
Run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of Spartalizumab
From first dose of spartalizumab to last dose, up to 0.9 years
Run-in Part: Dose Intensity of Capmatinib
From first dose of capmatinib to last dose, up to 2.4 years
Run-in Part: Dose Intensity of Spartalizumab
From first dose of spartalizumab to last dose, up to 0.9 years
Run-in Part: Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1
Up to approximately 2 years and 4 months
- +27 more secondary outcomes
Study Arms (3)
Run-in part
EXPERIMENTALcapmatinib in combination with spartalizumab
Randomized part - Arm 1 spartalizumab
EXPERIMENTALcapmatinib in combination with spartalizumab
Randomized part - Arm 2 placebo
EXPERIMENTALcapmatinib in combination with placebo
Interventions
Concentrate for solution for infusion
Film-coated tablet
dextrose 5% in water (D5W) for infusion
Eligibility Criteria
You may qualify if:
- Histologically confirmed locally advanced or metastatic NSCLC which is EGFR wild-type, ALK rearrangement negative and METΔex14 mutated
- No prior systemic therapy for advanced/metastatic disease (neo-adjuvant/adjuvant treatment completed \> 12 months before relapse are permitted)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Measurable disease as per RECIST 1.1
- Known PD-L1 tumor expression status (applicable to Randomized part 2 only)
You may not qualify if:
- Prior treatment with a PD-1/PD-L1 inhibitor, MET inhibitor or HGF inhibitor
- Presence of symptomatic CNS metastases or requiring local CNS-directed therapy (radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry
- Impaired cardiac function or clinically significant cardiac disease
- Presence or history of interstitial lung disease, non-infectious pneumonitis or interstitial pneumonitis, including clinically significant radiation pneumonitis
- History of allogenic bone marrow or solid organ transplant
- Radiotherapy to lung fields ≤ 4 weeks or to any other anatomic site ≤ 2 weeks prior to start of study treatment (palliative radiotherapy for bone lesions is allowed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Massachusetts General Hospital Liver and Kidney TX
Boston, Massachusetts, 02114, United States
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Montreal, Quebec, H4A 3J1, Canada
Novartis Investigative Site
Lille, 59000, France
Novartis Investigative Site
Paris, 75014, France
Novartis Investigative Site
Pierre-Bénite, 69495, France
Novartis Investigative Site
Berlin, 13125, Germany
Novartis Investigative Site
Cologne, 50937, Germany
Novartis Investigative Site
Gerlingen, 70839, Germany
Novartis Investigative Site
Tübingen, 72076, Germany
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Ōsaka-sayama, Osaka, 589 8511, Japan
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Valencia, Valencia, 46014, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 26, 2020
Study Start
August 19, 2020
Primary Completion
December 14, 2022
Study Completion
January 26, 2023
Last Updated
October 9, 2024
Results First Posted
February 6, 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.