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

NCT07468071 · tracked via the Priya Life Science China tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 1/2

Started

2026-06-08

Last updated

2026-09-18

Condition(s) studied

Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung CancerAdvanced Solid Tumors Harboring the KRAS G12C Mutation

Investigational drug(s) / intervention(s)

OpnurasibTNO155trametinibcetuximabtislelizumab

Opnurasib: 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.

TNO155: 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.

trametinib: 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.

cetuximab: 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.

tislelizumab: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Key Inclusion Criteria: * Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment. * Participant has received at least 6 cycles of opnurasib in a parent study. * Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator. * Participants currently receiving treatment in one of the KontRASt studies, including those who have not experienced disease progression or who are continuing treatment beyond initial disease progression, may be eligible to enroll in the rollover study if, in the Investigator's judgment, they are expected to continue deriving clinical benefit from treatment with opnurasib (alone or in combination). Clinical benefit, as assessed by the Investigator, may be reflected by delayed disease progression, improvement in disease-related symptoms, improvement in overall quality of life, or a combination of these factors. Key Exclusion Criteria: * Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study. * Participant is not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. * Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study. * Participant has known actionable mutations, such as EGFR-sensitizing mutation, ALK rearrangement, or others, identified during the participation in the parent trial for which there are available treatment options. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Number of participants receiving opnurasib as single agent or in combination with other study treatments — Assessed up to approximately 3 years
The number of participants enrolled and receiving opnurasib as single agent or in combination with other study treatments under the rollover study, will be summarized by treatment arm.
Duration of exposure to study treatment — Assessed up to approximately 3 years
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.

Trial sites (20)

Facility	City	Region	Status
Novartis Investigative Site	Sint-Niklaas	Oost Vlaanderen	Active Not Recruiting
Novartis Investigative Site	Leuven	Belgium	Recruiting
Novartis Investigative Site	Montreal	Quebec	Active Not Recruiting
Novartis Investigative Site	Sherbrooke	Quebec	Active Not Recruiting
Novartis Investigative Site	Guangzhou	Guangdong	Active Not Recruiting
Novartis Investigative Site	Changsha	Hunan	Active Not Recruiting
Novartis Investigative Site	Copenhagen	Denmark	Recruiting
Novartis Investigative Site	Bron	France	Active Not Recruiting
Novartis Investigative Site	Villejuif	France	Recruiting
Novartis Investigative Site	Milan	MI	Active Not Recruiting
Novartis Investigative Site	Milan	MI	Active Not Recruiting
Novartis Investigative Site	Roma	RM	Recruiting
Novartis Investigative Site	Kashiwa	Chiba	Active Not Recruiting
Novartis Investigative Site	Koto Ku	Tokyo	Active Not Recruiting
Novartis Investigative Site	Kuching	Sarawak	Active Not Recruiting
Novartis Investigative Site	Seoul	South Korea	Active Not Recruiting
Novartis Investigative Site	Pamplona	Navarre	Active Not Recruiting
Novartis Investigative Site	Barcelona	Spain	Recruiting
Novartis Investigative Site	Madrid	Spain	Recruiting
Novartis Investigative Site	Valencia	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07468071 on ClinicalTrials.gov ↗ ← All trials in China