RecruitingPhase 1Phase 2NCT07468071

Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments


Sponsor

Novartis Pharmaceuticals

Enrollment

40 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Opnurasib, a drug called TNO155, and others for people with advanced solid tumors harboring the kras g12c mutation and locally advanced or metastatic kras g12c-mutated non-small cell lung cancer. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpnurasib

Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

DRUGTNO155

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

DRUGtrametinib

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

BIOLOGICALcetuximab

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

BIOLOGICALtislelizumab

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.


Locations(20)

Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Copenhagen, Denmark

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07468071