marked.bio

KRAS G12C inhibitor (OFF state) · small molecule

divarasib

6 active trials across 6 of our biomarkers, targeting KRAS G12C. Not approved for any biomarker on marked.bio yet.

Also known as GDC-6036, RG6330.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
KRAS G12C 6 6 Phase 3
ALK fusion 1 1 Phase 2
BRAF V600E 1 1 Phase 2
NTRK1/2/3 fusion 1 1 Phase 2
RET fusion or mutation 1 1 Phase 2
ROS1 fusion 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of divarasib.

  1. Roche 6

Trials

6 of 6 trials shown

  1. A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

    Recruiting Phase 3 Roche Started 2026Primary completion 2032-01 NCT07541170

    divarasibpembrolizumabnivolumab

    Documentation of the presence of a KRAS G12C mutation

    KRAS G12CNon-small Cell Lung Cancer

  2. A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Recruiting Phase 3 Roche Started 2025Primary completion 2028-11 NCT06793215

    divarasibpembrolizumabpemetrexedcarboplatincisplatin

    Documentation of the presence of a KRAS G12C mutation

    KRAS G12CNon-Small Cell Lung Cancer, KRAS G12C Lung Cancer

  3. A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 Roche Started 2024Primary completion 2026-05 NCT06497556

    divarasibsotorasib FDA EUadagrasib FDA EU

    Documentation of the presence of a KRAS G12C mutation

    KRAS G12CNon-Small Cell Lung Cancer, KRAS G12C Lung Cancer

  4. A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

    Recruiting Phase 1/2 Roche Started 2023Primary completion 2032-01 NCT05789082

    divarasibpembrolizumabcarboplatincisplatinpemetrexed

    …ipants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

    KRAS G12CNon-Small Cell Lung Cancer

  5. A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 2 Roche Started 2020Primary completion 2026-11 NCT04302025

    alectinibentrectinibvemurafenibcobimetinibpralsetinibatezolizumabSBRTChemotherapydivarasib

    …on in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation

    KRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon-small Cell Lung Cancer

  6. A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

    Active, not recruiting Phase 1 Roche Started 2020Primary completion 2027-12 NCT04449874

    divarasibatezolizumabcetuximabbevacizumaberlotinibGDC-1971inavolisib

    Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.

    KRAS G12CNon-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors