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Also known as GDC-6036
Divarasib · 6 trials · 5 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) |
| 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. |
| Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) | EXPERIMENTAL | Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II. |
| Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) | EXPERIMENTAL | Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab. |
| Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) | EXPERIMENTAL | Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab. |
| Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with bevacizumab. |
| Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) | EXPERIMENTAL | Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib. |
| Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II. |
| Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II. |
| 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 |
| GDC-6036 | DRUG | The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation). |
| Atezolizumab | DRUG | A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles. |
| Cetuximab | DRUG | Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m\^2) IV infusion followed by 250 mg/m\^2 IV infusion weekly in 21 day cycles. |
| Bevacizumab | DRUG | A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles. |
| Erlotinib | DRUG | 150 mg of erlotinib will be administered PO QD in 21 day cycles. |
| GDC-1971 | DRUG | The starting dose of GDC-1971 will be determined from its single-agent dose escalation. |
| Inavolisib | DRUG | The starting dose of inavolisib will be determined from its single-agent dose escalation. |
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 KRAS G12C-positive non-small cell lung cancer (NSCLC). It is also being evaluated in a pharmacokinetic study in people with hepatic impairment. It is not approved for any indication and remains in clinical development.
Divarasib targets KRAS, specifically the KRAS G12C mutation. It is a small molecule designed to inhibit this mutant form of the KRAS protein, which drives tumor growth in cancers such as non-small cell lung cancer. The drug is being studied in patients whose tumors carry the KRAS G12C mutation.
Divarasib is being developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating the drug in KRAS G12C-positive non-small cell lung cancer and in participants with hepatic impairment.
Divarasib is in Phase 3 clinical development. Multiple Phase 3 trials are ongoing, including studies in resected and advanced KRAS G12C-positive non-small cell lung cancer. A Phase 1 pharmacokinetic trial in healthy participants and those with hepatic impairment has been completed. The drug is investigational and has not been approved by the FDA.
Divarasib is being studied in several trials, including NCT07541170 in resected stage II-III KRAS G12C-positive NSCLC, NCT06793215 in previously untreated advanced non-squamous NSCLC, and NCT06497556 comparing it with sotorasib or adagrasib in previously treated advanced NSCLC. A completed Phase 1 trial, NCT06734208, evaluated pharmacokinetics in hepatic impairment.
Yes, Divarasib is also known as GDC-6036. Both names refer to the same investigational KRAS G12C inhibitor being developed by Roche. The alternative designation GDC-6036 may appear in scientific literature and early development documents.