Suspended

Long-term Safety Assessment of Capmatinib Monotherapy or Combination Treatment in Previously Treated Patients

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Study Aim

This study aims to evaluate the safety and tolerability of Capmatinib monotherapy or combination treatment in previously treated patients, by monitoring the number of participants who experience adverse events.

What is being tested

Capmatinib

+ Gefitinib

+ Nazartinib

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 100 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2017
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2017

Actual date on which the first participant was enrolled.

This study focuses on the long-term safety of a drug called Capmatinib (INC280), either used alone or in combination with other treatments. Participants are those who have previously benefited from Capmatinib in a past Novartis-sponsored study. The goal is to understand the safety and benefits of continuing Capmatinib treatment for an extended period. This research is important as it could provide valuable insights into the long-term effects of Capmatinib, potentially improving treatment strategies for conditions it targets. During the study, participants will continue their Capmatinib treatment without a screening period. They will visit the study center for resupply of the medication and safety assessments, following local practices. Treatment continues until the participant no longer benefits, experiences unacceptable toxicities, withdraws consent, or the study treatment becomes commercially available. Participants will be monitored for safety for 30 days after the last dose. The primary outcome measured is the number of participants who experience adverse events, which will be collected at every visit to assess the safety and tolerability of the treatment.

Official TitleAn Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.
NCT03040973
Principal SponsorNovartis Pharmaceuticals
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

4 inclusion criteria required to participate
Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition participants to rollover study) as single agent or in combination or is receiving a combination treatment alone. This includes all participants treated with capmatinib in combination with other treatment that permanently discontinued capmatinib for any reason but are still receiving the combination treatment as single agent. In order to receive the combination treatment as single agent in the rollover study, the treatment needs to be not accessible to the participant outside a clinical trial (e.g. commercially not available or reimbursed).
Participant is currently deriving clinical benefit from study treatment as determined by the Investigator
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
Written informed consent obtained prior to enrolling in the rollover study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
5 exclusion criteria prevent from participating
Participant is currently not receiving any study treatment due to unresolved toxicities for which study treatment dosing has been interrupted or permanently discontinued in the parent protocol (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study treatment dosing to resume)
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for at least 7 days or following combination treatment parent trial recommendation (whichever is longer) of study treatment after stopping medication. Highly effective contraception methods include:
Concurrent participation in another clinical study other than a parent clinical study
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Group II

Experimental
Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Group III

Experimental
Starting dose of the study treatment for patients should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Group IV

Experimental
Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
Suspended

Novartis Investigative Site

Leuven, Belgium
Suspended

Novartis Investigative Site

Edmonton, Canada
Suspended

Novartis Investigative Site

Shanghai, China
Suspended15 Study Centers