Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone

NCT03040973 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CINC280A2X02B2024-510948-31-00
• Study Type: interventional
• Target: 29
• Locations: 11 countries
• Sites: 15

Brief Summary

The purpose of this study is to assess long-term safety and provide continued study treatment access to eligible participants who are judged by the Investigator to benefit from continued treatment with capmatinib monotherapy or in combination with other treatments or with the combination treatment alone in a Novartis sponsored study

Conditions

Advanced Solid Tumors Which Are cMET-dependent

Keywords

capmatinib; INC280; Nazartinib; Gefitinib; Osimertinib; EGF816; NSCLC; EGFR inhibitor; METex14; Non Small Cell Lung Cancer; MET inhibitors; rollover protocol; parent protocol

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Collection of adverse events and serious adverse events at every visit. Safety assessment will be performed and include local laboratory test monitoring in addition to local standard of care assessments.

  Day 1 up to 10 years, assessed every 12 weeks

Study Arms (4)

Capmatinib

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.

Drug: Capmatinib

Capmatinib + Nazartinib

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.

Drug: Capmatinib; Drug: Nazartinib

Capmatinib + Gefitinib

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.

Drug: Capmatinib; Drug: Gefitinib

Capmatinib + Osimertinib

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.

Drug: Capmatinib; Drug: Osimertinib

Interventions

Capmatinib DRUG

Tablet for oral use; 150 mg, 200 mg; twice a day

Also known as: INC280

Capmatinib; Capmatinib + Gefitinib; Capmatinib + Nazartinib; Capmatinib + Osimertinib

Nazartinib DRUG

Capsule for oral use; 25 mg, 50 mg; once a day

Also known as: EGF816

Capmatinib + Nazartinib

Gefitinib DRUG

tablets for oral use; 250mg; once a day

Capmatinib + Gefitinib

Osimertinib DRUG

Tablets for oral use; 40 mg, 80 mg; once a day.

Capmatinib + Osimertinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Participants who received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and COVID-19 vaccines) within 30 days prior to the first dose of study treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200433, China

Location

Novartis Investigative Site

Kunming, Yunnan, 650106, China

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Dijon, Cote D Or, 21034, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Perugia, PG, 06129, Italy

Location

Novartis Investigative Site

Milan, 20141, Italy

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

capmatinib; nazartinib; Gefitinib; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 2, 2017
• Study Start: August 23, 2017
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); KR (2); US (1); FR (1); SG (1); CA (1); DE (2); ES (1); CN (2); IT (2); BE (1)