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

Study Details

Brief 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.

Conditions

Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer

Advanced Solid Tumors Harboring the KRAS G12C Mutation

Study ID

NCT07468071

Start date

Jun 8, 2026

Status verified date

Sep, 2026

Completion date

Sep 11, 2029

Anticipated

Primary completion date

Jun 11, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: opnurasib single agent

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.

experimental: Group 2: opnurasib + TNO155

Eligible participants will receive the same starting dose and regimen of opnurasib and 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.

experimental: Group 3: opnurasib + trametinib

Eligible participants will receive the same starting dose and regimen of opnurasib and 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.

experimental: Group 4: opnurasib + cetuximab

Eligible participants will receive the same starting dose and regimen of opnurasib and 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.

experimental: Group 5: opnurasib + tislelizumab

Eligible participants will receive the same starting dose and regimen of opnurasib and 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.

Interventions

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.

Primary outcome measure

Number of participants receiving opnurasib as single agent or in combination with other study treatments [ Time Frame: Assessed up to approximately 3 years ]
Duration of exposure to study treatment [ Time Frame: Assessed up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

+81337978748 novartis.email@novartis.com

Locations

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

OpnurasibRollover 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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information