Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zoldonrasib · 2 trials · 15 indications
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).
OS is defined as the time from randomization until death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: zoldonrasib + pembrolizumab + chemotherapy doublet | EXPERIMENTAL | study drug in combination with pembrolizumab and platinum-based chemotherapy doublet |
| Arm B: placebo + pembrolizumab + chemotherapy doublet | PLACEBO_COMPARATOR | placebo in combination with pembrolizumab and platinum-based chemotherapy doublet |
| Arm A: zoldonrasib + chemotherapy | EXPERIMENTAL | study drug in combination with Investigator choice chemotherapy (mFFX or GnP) |
| Arm B: placebo + chemotherapy | PLACEBO_COMPARATOR | placebo in combination with Investigator choice chemotherapy (mFFX or GnP) |
| Name | Type | Description |
|---|---|---|
| zoldonrasib | DRUG | oral tablets |
| Placebo | DRUG | oral tablets |
| pembrolizumab | DRUG | IV infusion or Subcutaneous injection |
| pemetrexed + cisplatin /carboplatin | DRUG | IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin |
| Oxaliplatin | DRUG | IV infusion |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion |
| 5-Fluorouracil | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Gemcitabine (GEM) | DRUG | IV infusion |
| Nab-paclitaxel | DRUG | IV infusion |
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC. * Known PD-L1 status * Documented RAS G12D mutati...
Top 20 of 68 competitors
Zoldonrasib is an investigational small molecule being studied for the treatment of KRAS G12D-mutated cancers, specifically metastatic pancreatic adenocarcinoma (PDAC) and metastatic non-squamous non-small cell lung cancer (NSCLC). It is currently in Phase 3 clinical trials as a first-line treatment in combination with chemotherapy.
Zoldonrasib targets the KRAS G12D mutation, a specific genetic alteration found in certain cancers. It is being evaluated in patients with KRAS G12D-mutated pancreatic cancer and non-small cell lung cancer, where it is combined with standard chemotherapy regimens.
Zoldonrasib is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVMD. The company is conducting Phase 3 clinical trials for this investigational drug in pancreatic cancer and NSCLC.
Zoldonrasib is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Breakthrough Therapy designation, which is intended to expedite the development and review of drugs for serious conditions.
Zoldonrasib is being studied in two Phase 3 trials. NCT07621718 evaluates Zoldonrasib plus chemotherapy versus placebo plus chemotherapy in metastatic KRAS G12D-mutated pancreatic adenocarcinoma. NCT07777822 evaluates pembrolizumab plus chemotherapy with or without Zoldonrasib in metastatic non-squamous KRAS G12D-mutated NSCLC.
No alternative names for Zoldonrasib have been disclosed. It is a distinct investigational compound developed by Revolution Medicines, Inc., and is not known to be marketed under any other name.