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Divarasib

Phase 3Small molecule

Divarasib is one of 76 small molecule programs targeting Solid Tumor. It is currently in Phase 3.

2

Indications

14

Total Trials

9

Active Trials

75

Competitors

Pipeline

Status by Indication[3][1]

Indication

Solid TumorActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Solid TumorPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Sacituzumab Tirumotecan

Divarasib

Ds-1062a

SCTB14

SSinocelltech Ltd.

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Valemetostat Tosylate

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

PreclinicalActive, not recruiting

Non-Small Cell Lung Cancer

NCT03178552

Q4 2029

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT06497556

Q2 2030

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT04302025

Q3 2030

Phase 1Recruiting

Metastatic Colorectal Cancer

NCT04929223

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer7 trials

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06497556·338 enrolled

A Multicenter, Open-Label, Expanded Access Program to Provide Divarasib to Patients With Previously Treated KRAS G12c-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

Temporarily not available· Roche logo

Roche··NCT07783009

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

Show 4 more trials

A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 3·NCT07541170·400 enrolled

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Recruiting· Roche logo

Roche·Preclinical·NCT05789082·320 enrolled

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 3·NCT06793215·600 enrolled

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Active, not recruiting· Roche logo

Roche·Preclinical·NCT03178552·1,000 enrolled

Tics2 trials

A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT06835465·18 enrolled

A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT06690138·18 enrolled

Hepatic Function1 trial

A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

Completed· Roche logo

Roche·Phase 1·NCT06734208·31 enrolled

Clinical Trial1 trial

A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT06677957·19 enrolled

Metastatic Colorectal Cancer1 trial

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Recruiting· Roche logo

Roche·Phase 1·NCT04929223·542 enrolled

2 more indications

Solid Tumor1 trial

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

Unspecified1 trial

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Recruiting· Roche logo

Roche·Phase 3·NCT05862285·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Divarasib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Divarasib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Divarasib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Roche

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