> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-daraxonrasib-and-daraxonrasib-gnp-as-first-line-4272d760-c06f-432f-94ac-f58a87cc77a1 > Record changed: 2026-11-04 # Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma NCT07491445 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Participants 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Lead sponsor Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Start date 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) Number of sites 82 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Acronym** RASolute 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Short title** Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Official title** RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Dates **Completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **First posted** 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Registry last updated** 2026-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Primary completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Start date** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Size and sites **Participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Planned participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Number of sites** 82 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Lead sponsor** Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Identifiers **Registry ID** NCT07491445 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **ClinicalTrials.gov ID** NCT07491445 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Outcomes ### Primary outcomes 1. Progression free survival (PFS) Timeframe: Up to approximately 2 years PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator. 2. Overall survival (OS) Timeframe: Up to approximately 2 years OS is defined as the time from randomization until death from any cause. ### Secondary outcomes 1. Objective response rate (ORR) Timeframe: Up to approximately 2 years Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator. 2. Duration of response (DOR) Timeframe: Up to approximately 2 years DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator. 3. Concentration of daraxonrasib in Arm A and B Timeframe: Up to Cycle 5 Day 1 (each cycle is 28 days) Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits. 4. Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) Timeframe: Up to approximately 2 years EORTC QLQ-PAN26 consists of 26 items assessing patient-reported health-related quality of life, including symptoms and impacts. Change from baseline in the pain subscale scores will be evaluated, with higher scores indicating greater symptom burden. 5. Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Timeframe: Up to approximately 2 years EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning. 6. Incidence of adverse events (AEs) Timeframe: Up to approximately 2 years Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 7. Changes in vital signs Timeframe: Up to approximately 2 years Number of patients with clinically significant changes in vital signs 8. Changes in clinical laboratory test values Timeframe: Up to approximately 2 years Number of patients with changes from baseline in clinical laboratory test values Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically or cytologically confirmed pancreatic adenocarcinoma. - Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. - Documented RAS mutation status, either mutant or wild-type. - Measurable disease per RECIST v1.1. - Adequate organ function (bone marrow, liver, kidney, coagulation). - Able to take oral medications. ### Exclusion criteria - Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting. - Active or known history of untreated central nervous system metastatic disease. - Any conditions that may affect the ability to take or absorb study drug. - Major surgery within 28 days prior to randomization. - Patient is unable or unwilling to comply with protocol-required study visits or procedures. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Sites - Mayo Clinic - ScottsdalePhoenix, United StatesActive, not recruiting - Honor Health Research InstituteScottsdale, United StatesActive, not recruiting - University of California Los Angeles Health - Hematology/OncologyLos Angeles, United StatesActive, not recruiting - University of California San FranciscoSan Francisco, United StatesActive, not recruiting - Mayo Clinic Cancer Center- FloridaJacksonville, United StatesActive, not recruiting - H Lee Moffitt Cancer Center and Research InstituteTampa, United StatesActive, not recruiting - Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesActive, not recruiting - Dana-Farber Cancer InstituteBoston, United StatesActive, not recruiting - Henry Ford Health SystemDetroit, United StatesActive, not recruiting - Mayo Clinic Cancer Center- RochesterRochester, United StatesActive, not recruiting - Comprehensive Cancer Centers of NevadaHenderson, United StatesActive, not recruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesActive, not recruiting - Duke University Medical CenterDurham, United StatesActive, not recruiting - University of Cincinnati Cancer CenterCincinnati, United StatesActive, not recruiting - Taylor Cancer Research CenterMaumee, United StatesActive, not recruiting - SCRI Oncology PartnersNashville, United StatesActive, not recruiting - SCRI - Texas Oncology DallasDallas, United StatesActive, not recruiting - MD Anderson Cancer CenterHouston, United StatesActive, not recruiting - Huntsman Cancer InstituteSalt Lake City, United StatesActive, not recruiting - Virginia Cancer SpecialistsFairfax, United StatesActive, not recruiting - Virginia Mason Medical CenterSeattle, United StatesActive, not recruiting - St. George HospitalKogarah, AustraliaRecruiting - Prince of Wales HospitalRandwick, AustraliaRecruiting - Calvary Mater NewcastleWaratah, AustraliaRecruiting - Royal Brisbane and Women's HospitalHerston, AustraliaRecruiting And 57 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07491445) ## Related records ### Drugs (3) - [Daraxonrasib](https://trialight.com/data/asset/daraxonrasib-9873cc14-518a-5809-9186-ea8182ea0bcb.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Nab-paclitaxel](https://trialight.com/data/asset/nab-paclitaxel-9e43424b-471d-5b8f-bfde-18406e7e9581.md) ### Lead sponsors (1) - [Revolution Medicines, Inc.](https://trialight.com/data/company/revolution-medicines-inc-fb145d13-dec5-4356-b5c0-db990e1d4b8e.md) ### Conditions (6) - [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) - [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) Primary condition - [Pancreatic adenocarcinoma](https://trialight.com/data/condition/pancreatic-adenocarcinoma-fd65444c-0bc5-53ed-8c6a-62d9809145d0.md) - [Pancreatic adenosquamous carcinoma](https://trialight.com/data/condition/pancreatic-adenosquamous-carcinoma-3bc99d24-2067-5875-b515-fdda19e7f620.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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