A Phase 1/2 interventional study of Elironrasib and Daraxonrasib in Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines, Inc.. Recruiting at 56 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Revolution Medicines, Inc. · Phase 1/2, Interventional, and Treatment
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.
The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 534 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Revolution Medicines, Inc. is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Histology: documented, KRAS G12C-mutated, advanced or solid tumors not amendable to curative therapy
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 2 only
Drug: Elironrasib
Phase 2 only
Drug: Daraxonrasib
Phase 1b and 2
Drug: Elironrasib · Drug: Daraxonrasib
oral tablets
Also known as: RMC-6291
oral tablets
Also known as: RMC-6236
Number of patients with adverse events (AEs) in Phase 1b
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Up to approximately 3 years
Changes in vital signs in Phase 1b
Number of patients with clinically significant changes in vital signs
Time frame: Up to approximately 3 years
Changes in clinical laboratory test values in Phase 1b
Number of patients with clinically significant changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Dose Limiting Toxicities in Phase 1b
Number of participants with dose limiting toxicities
Time frame: 21 days
Changes in ECGs in Phase 1b
Number of patients with clinically significant changes in ECGs
Time frame: Up to approximately 3 years
Overall Response Rate (ORR) in Phase 2
Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)
Time frame: Up to approximately 3 years
Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib
Cmax
Time frame: up to 21 weeks
Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib
Tmax
Time frame: up to 21 weeks
Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib
AUC
Time frame: up to 21 weeks
Elimination Half-Life of Elironrasib and Daraxonrasib
t1/2
Time frame: up to 21 weeks
Ratio of accumulation of Elironrasib and Daraxonrasib from a single dose to steady state with repeated dosing
accumulation ratio
Time frame: up to 21 weeks
Overall Response Rate (ORR) in Phase 1b
Overall response rate per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Duration of response per RECIST v1.1
Time frame: Up to approximately 3 years
Disease Control Rate in Phase 1b
Disease Control rate per RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) in Phase 1b
Time to response per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS)
Progression-free survival per RECIST v1.1
Time frame: Up to approximately 3 years
Number of patients with AEs in Phase 2
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5
Time frame: Up to approximately 3 years
Changes in vital signs in Phase 2
Number of patients with clinically significant changes in vital signs
Time frame: Up to approximately 3 years
Changes in clinical laboratory values in Phase 2
Number of patients with clinically significant changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Overall Survival (OS) in Phase 2
OS is defined as time from enrollment until death from any cause
Time frame: Up to approximately 3 years
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Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for Dec 2028, 61 months after the start.
Of 308 industry-sponsored phase 1/2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 77. This study's planned 61 months is close to that.
Counting every sponsor, half of 431 studies reached it within 63 months; a quarter within 42 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Elironrasib · Daraxonrasib
Carcinoma, Non-Small-Cell Lung →