NCT07349537 is a Phase 1 clinical trial of RMC-5127 in Non-small Cell Lung Cancer (NSCLC), sponsored by Revolution Medicines, Inc..

Who is sponsoring NCT07349537?

NCT07349537 is sponsored by Revolution Medicines, Inc..

What drugs are being tested in NCT07349537?

Interventions in NCT07349537: RMC-5127, daraxonrasib, cetuximab.

What condition does NCT07349537 study?

NCT07349537 studies Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), PDAC, CRC, NSCLC, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Solid Tumors.

Is NCT07349537 still recruiting?

NCT07349537 is currently recruiting now. Last updated 28 May 2026.

Last reviewed 2026-05-28 · How we verify

NCT07349537

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Recruiting now Phase 1 Last updated 28 May 2026

What this trial tests

Phase 1 trial testing RMC-5127 in Non-small Cell Lung Cancer (NSCLC) in 574 participants. Currently enrolling.

Timeline

8 January 2026

Primary endpoint
1 April 2028

1 October 2028

Quick facts

Lead sponsor	Revolution Medicines, Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	574
Start date	8 January 2026
Primary completion	1 April 2028
Estimated completion	1 October 2028
Sites	5 locations across United States

Drugs / interventions tested

RMC-5127 — full drug profile →
daraxonrasib — full drug profile →
cetuximab (cetuximab) — full drug profile →

Conditions studied

Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →
Colorectal Cancer (CRC) — all drugs for Colorectal Cancer (CRC) →
Pancreatic Adenocarcinoma — all drugs for Pancreatic Adenocarcinoma →
Pancreatic Ductal Adenocarcinoma (PDAC) — all drugs for Pancreatic Ductal Adenocarcinoma (PDAC) →

Sponsor

Revolution Medicines, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of patients with adverse events (AEs)
Time frame: Up to approximately 3 years
Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5
Changes in vital signs
Time frame: Up to approximately 3 years
Number of patients with changes from baseline in vital signs
Changes in electrocardiogram (ECG) test values
Time frame: Up to approximately 3 years
Number of patients with changes from baseline in ECG test values
Changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Number of patients with changes from baseline in clinical laboratory test values
Dose Limiting Toxicities
Time frame: Up to 28 days
Number of patients with dose limiting toxicities

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

NCT07361497 — A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresec · Phase 3 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
NCT07291037 — Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic N · Phase 3 · recruiting
NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting

Other Revolution Medicines, Inc. trials

Trials by the same sponsor.

NCT07252232 — Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) · Phase 3 · recruiting
NCT06881784 — Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) · Phase 3 · recruiting
NCT06445062 — Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors · Phase 1, PHASE2 · recruiting
NCT06040541 — Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors · Phase 1 · recruiting
NCT05462717 — Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07349537 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Revolution Medicines, Inc.
Last refreshed: 28 May 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07349537.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing