Approval Probability
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Adjusted LOA
ML Risk
Divarasib · 8 trials · 4 indications
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)
OS is defined as the time from randomization to death from any cause
| Arm | Type | Description |
|---|---|---|
| Divarasib | EXPERIMENTAL | Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days). |
| Control: Pembrolizumab or Nivolumab or Observation | ACTIVE_COMPARATOR | Participants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation. |
| Divarasib + Pembrolizumab | EXPERIMENTAL | Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W) |
| Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin | ACTIVE_COMPARATOR | Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W |
| KRAS G12C inhibitor | ACTIVE_COMPARATOR | Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID) |
| Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of Divarasib on Day 1. |
| Treatment B | EXPERIMENTAL | Participants will receive Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8. |
| Cohort 1 | EXPERIMENTAL | Participants will receive a single oral dose of Divarasib on Day 1. |
| Cohort 2 | EXPERIMENTAL | Participants will receive a single oral dose of Divarasib on Day 1. |
| Cohort 3 | EXPERIMENTAL | Participants will receive a single oral dose of Divarasib on Day 1. |
| Cohort 4 | EXPERIMENTAL | Participants will receive a single oral dose of Divarasib on Day 1. |
| Cohort A - Combination Dose Finding + Dose Expansion | EXPERIMENTAL | Participants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W). During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab. |
| Cohort B - Combination Dose Finding + Dose Expansion | EXPERIMENTAL | Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed. |
| Cohort C - Dose Expansion | EXPERIMENTAL | Participants enrolled in this cohort will receive one dose level of divarasib QD. |
| Cohort D - Dose Expansion | EXPERIMENTAL | Participants enrolled in this cohort will receive one dose level of divarasib QD. |
| Name | Type | Description |
|---|---|---|
| Divarasib | DRUG | Divarasib will be administered orally as per the schedule specified in the respective arm. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days). |
| Nivolumab | DRUG | Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days). |
| Pemetrexed | DRUG | Pemetrexed will be administered via IV infusion Q3W |
| Carboplatin | DRUG | Carboplatin will be administered via IV infusion Q3W |
| Cisplatin | DRUG | Cisplatin will be administered via IV infusion Q3W |
| Sotorasib | DRUG | Sotorasib will be administered orally QD |
| Adagrasib | DRUG | Adagrasib will be administred orally BID |
| Rifampin | DRUG | Rifampin will be administered QD on Days 1 to 7 and Days 9 to 13 and as a single oral dose on Day 8 as specified for the respective period. |
| Itraconazole | DRUG | Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period. |
| Digoxin | DRUG | Digoxin will be administered together with Rosuvastatin as a drug cocktail as specified for the respective period |
| Rosuvastatin | DRUG | Rosuvastatin will be administered together with Digoxin as a drug cocktail as specified for the respective period |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology * Participants must have had complete resection of NSCLC * Prior treatment with neoadjuva...
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Divarasib is an investigational small molecule being studied for the treatment of KRAS G12C-positive advanced or metastatic non-small cell lung cancer, as well as for hepatic impairment and in healthy participants for drug interaction studies. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.
Divarasib targets the KRAS G12C mutation, a specific genetic alteration found in some cancers, particularly non-small cell lung cancer. The drug is designed to inhibit the activity of this mutated KRAS protein, which drives tumor growth. This targeted approach is being evaluated in clinical trials for patients with KRAS G12C-positive advanced or metastatic non-small cell lung cancer.
Divarasib is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the safety and efficacy of Divarasib in various patient populations, including those with KRAS G12C-positive non-small cell lung cancer and healthy participants for pharmacokinetic studies.
Divarasib is currently in Phase 1 clinical development. While it is being studied in a Phase 3 trial for non-small cell lung cancer, the overall development program is in early stages, with multiple Phase 1 trials completed or ongoing. Divarasib is investigational and has not been approved by regulatory authorities.
Divarasib is being evaluated in several clinical trials, including NCT06497556, a Phase 3 study comparing it to sotorasib or adagrasib in previously treated KRAS G12C-positive advanced or metastatic non-small cell lung cancer. Other trials include NCT06677957, NCT06690138, and NCT06835465, which are Phase 1 studies in healthy participants to assess drug interactions.
No, Divarasib is a distinct investigational drug being developed by Roche. It is being compared directly against sotorasib and adagrasib in a Phase 3 clinical trial for KRAS G12C-positive non-small cell lung cancer. While all three target the KRAS G12C mutation, they are separate compounds with different chemical structures and development programs.