Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Opnurasib · 1 trial · 2 indications
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.
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.
| Arm | Type | Description |
|---|---|---|
| Group 1: opnurasib single agent | EXPERIMENTAL | 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. |
| Group 2: opnurasib + TNO155 | EXPERIMENTAL | 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. |
| Group 3: opnurasib + trametinib | EXPERIMENTAL | 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. |
| Group 4: opnurasib + cetuximab | EXPERIMENTAL | 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. |
| Group 5: opnurasib + tislelizumab | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 deri...
Opnurasib is an investigational small molecule being developed for locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. It is also being studied in advanced solid tumors harboring the KRAS G12C mutation. The drug is currently in Phase 1 clinical development and is not yet approved.
Opnurasib is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of Opnurasib in patients with KRAS G12C-mutated cancers.
Opnurasib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is a 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.
Opnurasib is being evaluated in one active clinical trial with the identifier NCT07468071. This Phase 1 rollover study is recruiting 40 participants with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer or advanced solid tumors harboring the KRAS G12C mutation. The trial is enrolling adults aged 18 years and older.
Opnurasib targets the KRAS G12C mutation, a specific genetic alteration found in certain cancers. By targeting this mutation, the drug aims to inhibit the activity of the mutated KRAS protein, which plays a role in tumor growth. This mechanism is being studied in patients with KRAS G12C-mutated non-small cell lung cancer and other solid tumors.
Opnurasib is a distinct investigational drug developed by Novartis. While it targets the same KRAS G12C mutation as other drugs in this class, it is a separate compound with its own chemical structure and clinical development program. No alternative names for Opnurasib have been disclosed in the available information.