Clinical Trials

Opnurasib (JDQ-443) is under evaluation across several clinical trials targeting KRAS G12C-altered malignancies, predominantly non-small cell lung cancer, advanced solid tumors, colorectal cancer, and small cell lung carcinoma. Spanning Phase 1 dose-escalation, Phase 2 activity and neoadjuvant assessments, and Phase 3 comparative efficacy studies, these trials encompass advanced, metastatic, and resectable disease settings. Sponsored primarily by industry developer Novartis alongside academic partners including the Canadian Cancer Trials Group and Maastricht University Medical Center, recruitment statuses across the portfolio range from actively recruiting and active not recruiting to withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07468071 RECRUITING
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer; Advanced Solid Tumors Harboring the KRAS G12C Mutation
Novartis Pharmaceuticals
 2026-06-08 PHASE1; PHASE2
NCT05999357 WITHDRAWN
Non Small Cell Lung Cancer Metastatic; Brain Metastases, Adult; KRAS G12C
Maastricht University Medical Center
 2024-04-15 PHASE2
NCT04699188 ACTIVE_NOT_RECRUITING
KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small-Cell Lung; Carcinoma, Colorectal; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms
Novartis Pharmaceuticals
 2021-02-24 PHASE1; PHASE2
NCT05358249 ACTIVE_NOT_RECRUITING
KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small Cell Lung; Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumors; Neoplasms, Colorectal
Novartis Pharmaceuticals
 2022-10-24 PHASE1; PHASE2
NCT05714891 ACTIVE_NOT_RECRUITING
NSCLC
Canadian Cancer Trials Group
 2023-09-15 PHASE2
NCT05132075 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2022-06-15 PHASE3
NCT05445843 ACTIVE_NOT_RECRUITING
Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Novartis Pharmaceuticals
 2022-12-06 PHASE2
NCT05329623 COMPLETED
Small Cell Lung Carcinoma
Novartis Pharmaceuticals
 2022-05-03 PHASE1
NCT05445843 Recruiting
Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Novartis Pharmaceuticals|Novartis
 2022-12-06 Phase 2
NCT05132075 Recruiting
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals|Novartis
 2022-06-15 Phase 3
NCT05329623 Recruiting
Small Cell Lung Carcinoma
Novartis Pharmaceuticals|Novartis
 2022-05-03 Phase 1
NCT04699188 Recruiting
KRAS G12C Mutant Solid Tumors|Carcinoma Non-Small-Cell Lung|Carcinoma Colorectal|Cancer of Lung|Cancer of the Lung|Lung Cancer|Neoplasms Lung|Neoplasms Pulmonary|Pulmonary Cancer|Pulmonary Neoplasms
Novartis Pharmaceuticals|Novartis
 2021-02-24 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Opnurasib (JDQ-443) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Opnurasib (JDQ-443) is an orally bioavailable covalent inhibitor that selectively binds the inactive GDP-bound conformation of KRAS G12C, thereby preventing c-Raf recruitment and disrupting downstream mitogen-activated protein kinase signaling to arrest cellular proliferation. By suppressing this oncogenic driver, the compound induces apoptosis and suppresses tumor growth, providing therapeutic efficacy in KRAS G12C-mutated non-small cell lung cancer and solid tumors evaluated in clinical trials.

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>).

Jump to

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