A Phase 3 interventional study of daraxonrasib and gemcitabine in Pancreatic Cancer, Pancreatic Cancer Metastatic and PDAC, sponsored by Revolution Medicines, Inc.. Recruiting at 82 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Revolution Medicines, Inc. · Phase 3, Interventional, and Treatment
Netherlands, Spain, Belgium, Germany, Hong Kong, Italy
Among 370 studies testing gemcitabine in Pancreatic Neoplasms — 29 open to participants now, 44 under way, 5 of them phase 3. Gemcitabine · Pancreatic Neoplasms.
Among the 370 studies testing gemcitabine in Pancreatic Neoplasms, this one is the 4th largest by planned enrollment of the 353 interventional ones that give a count, is one of 6 that started in 2026, is one of 31 in phase 3, reaches primary completion later than 38 of the 43 other live ones, and was the 367th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →29 of the 370 studies testing gemcitabine in Pancreatic Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Revolution Medicines, Inc. · Sites in United States
Ages 18+
Smartwise Sweden AB · Sites in Sweden
Ages 18+
Shanghai Hengrui Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Dartmouth-Hitchcock Medical Center · Sites in United States
Ages 18+
Akeso · Sites in China
Ages 18–75
By country, each count listing its studies:
Gemcitabine: first FDA approval 1996 (GEMZAR). What it is approved for, and how studies give it, is on its page →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
370 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 239 · Phase 3 36 · Phase 4 2
First in 1995; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 900 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 37 across the 353 interventional studies. Of the 269 that completed or were terminated, 81 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 370 have an industry lead sponsor. The 10 most frequent:
Revolution Medicines, Inc. is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
13 studies in Pancreatic Neoplasms by Revolution Medicines, Inc.: 9 open now, 11 under way, 5 of them phase 3. Of 1 finished, 1 (100%) have results posted.
Among the 13 studies in Pancreatic Neoplasms by Revolution Medicines, Inc., this one is the 2nd largest by planned enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2026, is one of 5 in phase 3, reaches primary completion later than 5 of the 10 other live ones, and was the 10th registered.
Revolution Medicines, Inc.’s Pancreatic Neoplasms studies by the year they started, since 2019.
15 of the studies testing gemcitabine in Pancreatic Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06953999Phase 3AkesoA Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer | 2027-05-14 |
| NCT02340117SynerGene Therapeutics, Inc.Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer | 2026-12 |
| NCT03652428University of Maryland, BaltimorePhase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC) | 2026-12-31 |
| NCT04115163Anne NoonanBiologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer | 2026-12-31 |
| NCT04894643EBG MedAustron GmbHPreoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer | 2026-12-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 370 studies testing gemcitabine in Pancreatic Neoplasms, from their registry updates:
Among Revolution Medicines, Inc.’s 13 in Pancreatic Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
study drug
Drug: daraxonrasib
study drug in combination with chemotherapy
Drug: daraxonrasib · Drug: gemcitabine · Drug: nab-paclitaxel
SOC chemotherapy
Drug: gemcitabine · Drug: nab-paclitaxel
oral tablets
intravenous (IV) infusion
IV infusion
Progression free survival (PFS)
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.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.
Time frame: Up to approximately 2 years
Duration of response (DOR)
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.
Time frame: Up to approximately 2 years
Concentration of daraxonrasib in Arm A and B
Pre-dose trough and post-dose blood concentrations of daraxonrasib at selected visits.
Time frame: Up to Cycle 5 Day 1 (each cycle is 28 days)
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26)
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.
Time frame: Up to approximately 2 years
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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.
Time frame: Up to approximately 2 years
Incidence of adverse events (AEs)
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Up to approximately 2 years
Changes in vital signs
Number of patients with clinically significant changes in vital signs
Time frame: Up to approximately 2 years
Changes in clinical laboratory test values
Number of patients with changes from baseline in clinical laboratory test values
Time frame: Up to approximately 2 years
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Started Mar 2026 (actual). Primary completion is estimated for Jun 2028, 27 months after the start.
Of 84 phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 77. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
Netherlands, Spain, Belgium, Germany, Hong Kong, Italy
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Daraxonrasib · Gemcitabine · Albumin-Bound Paclitaxel