Last Update: Aug 27, 2026 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 ClinicalTrials.gov Identifier: [NCT07468071](https://clinicaltrials.gov/ct2/show/NCT07468071) Novartis Reference Number:CJDQ443B12105B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. Screening occurs on the same day as the parent study's End of Treatment visit, with informed consent and eligibility confirmation required before enrollment. Eligible participants start treatment within seven days and return for scheduled visits for drug resupply, safety monitoring, and confirmation of clinical benefit. Sites are expected to follow their local practice regarding the method and frequency of the assessments used to assess clinical benefit for the patient. Treatment continues until disease progression or other discontinuation criteria, and safety follow-up lasts 30-150 days depending on the last drug received. The study will remain open for up to three years from first participant visit or until all participants discontinue. Condition Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation Phase Phase1, Phase2 Overall Status Recruiting Number of Participants40 Start Date Jun 08, 2026 Completion Date Sep 11, 2029 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Biological ### 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. Drug ### 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. Biological ### 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. Drug ### 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. Drug ### 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. ## 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. Belgium #### Novartis Investigative Site Recruiting Leuven,3000,Belgium Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H4a 3j1,Canada #### Novartis Investigative Site Recruiting Sherbrooke,Quebec,J1h 5n4,Canada Denmark #### Novartis Investigative Site Recruiting Copenhagen,2100,Denmark France #### Novartis Investigative Site Recruiting Bron,69677,France Italy #### Novartis Investigative Site Recruiting Milan,MI,20133,Italy #### Novartis Investigative Site Recruiting Milan,MI,20162,Italy #### Novartis Investigative Site Recruiting Roma,RM,00128,Italy Spain #### Novartis Investigative Site Recruiting Pamplona,Navarre,31008,Spain ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: #### Novartis Pharmaceuticals Phone: [ +81337978748](tel:+81337978748) Email: