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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07468071
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Opnurasib — DRUG
    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 — DRUG
    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 — DRUG
    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 — BIOLOGICAL
    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 — BIOLOGICAL
    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 Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2029
Completion
Sep 17, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts