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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

RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation

Interventions: Opnurasib, TNO155, trametinib, cetuximab, tislelizumab

Countries: Belgium, Canada, China, Japan, Malaysia, South Korea

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (7)

Sint-Niklaas, Oost Vlaanderen, Belgium
Montreal, Quebec, Canada
Guangzhou, Guangdong, China
Kashiwa, Chiba, Japan
Koto Ku, Tokyo, Japan
Kuching, Sarawak, Malaysia
Seoul, South Korea