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.
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.
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.
Parallel
Opnurasib
DrugEligible 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
DrugEligible 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
DrugEligible 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/VaccineEligible 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/VaccineEligible 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.
Number of participants receiving opnurasib as single agent or in combination with other study treatments
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
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.
Incidence rate of Adverse Events (AEs)
The distribution of adverse events will be evaluated by analyzing the frequencies of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). In this study, TEAEs are defined as AEs with an onset date after the start of the treatment period, or events that were present before the treatment period but subsequently increased in severity, changed from not suspected to suspected of being related to study treatment, or evolved into SAEs after the start of the treatment period. The safety follow-up period will extend from the first administration of study treatment until: 1. 30 days after the last dose for participants receiving opnurasib as monotherapy or in combination with TNO155 or trametinib, 2. 60 days after the last dose for participants receiving opnurasib in combination with cetuximab, and 3. 150 days after the last dose for participants receiving opnurasib in combination with tislelizumab.
Number of participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
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