Clinical Trials

Multiple clinical trials sponsored primarily by Hoffmann-La Roche and Genentech evaluate divarasib across Phase 1 through Phase 3 development, encompassing safety, drug-drug interaction, precision oncology, and pivotal comparative studies. These evaluations focus on KRAS G12C–mutated malignancies—specifically non-small cell lung cancer, metastatic colorectal cancer, and advanced solid tumors—as well as pharmacokinetic profiles in healthy participants and individuals with hepatic impairment. Study statuses span from completed and active, not recruiting, to actively recruiting cohorts and available expanded access programs.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05862285 RECRUITING
Cancer
Hoffmann-La Roche
 2023-06-01 PHASE3
NCT04589845 ACTIVE_NOT_RECRUITING
Solid Tumors
Hoffmann-La Roche
 2021-01-18 PHASE2
NCT07541170 RECRUITING
Non-small Cell Lung Cancer
Hoffmann-La Roche
 2026-09-01 PHASE3
NCT05789082 RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2023-06-20 PHASE1; PHASE2
NCT04929223 RECRUITING
Metastatic Colorectal Cancer
Hoffmann-La Roche
 2021-10-22 PHASE1
NCT06793215 RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2025-10-24 PHASE3
NCT04449874 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Colorectal Cancer; Advanced Solid Tumors
Genentech, Inc.
 2020-07-29 PHASE1
NCT03178552 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2017-09-22 PHASE2; PHASE3
NCT04302025 RECRUITING
Non-small Cell Lung Cancer
Genentech, Inc.
 2020-11-06 PHASE2
NCT06497556 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; KRAS G12C Lung Cancer
Hoffmann-La Roche
 2024-09-23 PHASE3
NCT06734208 COMPLETED
Hepatic Impairment
Genentech, Inc.
 2025-01-31 PHASE1
NCT06835465 COMPLETED
Healthy Participants
Genentech, Inc.
 2025-02-21 PHASE1
NCT06690138 COMPLETED
Healthy Participants
Genentech, Inc.
 2024-11-15 PHASE1
NCT06677957 COMPLETED
Healthy Participants
Genentech, Inc.
 2024-11-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Divarasib (GDC-6036) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Divarasib irreversibly binds to the switch II pocket of GDP-bound inactive KRAS G12C, locking the GTPase in an inactive state and preventing functional GTP binding and pathway activation. This blockade suppresses downstream oncogenic signaling cascades to inhibit cell proliferation, driving anti-tumor responses in clinical trial settings such as KRAS G12C-mutated non-small cell lung cancer and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.