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AzTrials

Pancreatic CancerPhase 3NCT07409272

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

A Phase 3 study testing Setidegrasib, Oxaliplatin and Leucovorin in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Astellas Pharma Global Development, Inc. at 104 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Setidegrasib, Oxaliplatin and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
614 participants
Where
104 sitesin 11 countries
Study dates
17 Feb 2026to 31 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).
  • Participant has no option for surgical resection or radiotherapy with curative intent.
  • Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization.
  • Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib/placebo (or mFOLFIRINOX/NALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX/NALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1).
  • Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed).

Who cannot join

  • Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features.
  • Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
  • Participant has chronic inflammatory bowel disease, bowel obstruction and/or severe uncontrolled diarrhea.
  • Participant has peripheral sensory neuropathy with functional impairment.
  • Participant has ascites and/or pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter.
  • Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation.
Show all 13Show fewer
  • Participant has a history of interstitial lung disease or pulmonary fibrosis.
  • Participant has uncontrolled seizure disorder or refractory to antiepileptics.
  • Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism.
  • Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome.
  • Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses [i.e., 28 days; 1 cycle] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received [neo]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the [neo]adjuvant therapy).
  • Participant has had prior treatment with a KRAS G12D-targeted agent.
  • Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram [ECG]) > 470 msec during the screening period.

Trial locations and contacts

104 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Astellas Pharma Global Development, Inc. contact

800-888-7704

Astellas.registration@astellas.com

104 sites in 11 countries

United States54 sites, 54 recruiting

  • University of Michigan Health - University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

    Recruiting

  • Piedmont Healthcare - Piedmont Physicians Medical Oncology Atlanta

    Atlanta, Georgia, 30318

    Recruiting

  • University of Maryland School - Division of Hematology/Oncology

    Baltimore, Maryland, 21201

    Recruiting

  • Memorial Sloan Kettering - Hackensack - Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Recruiting

  • UVA Emily Couric Cancer Center

    Charlottesville, Virginia, 22903

    Recruiting

  • Facilities Design and Construction - Energy Advancement and Innovation Center

    Columbus, Ohio, 43210

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Recruiting

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

    Recruiting

  • Henry Ford Cancer, Detroit

    Detroit, Michigan, 48202

    Recruiting

  • Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care

    Edgewood, Kentucky, 41017

    Recruiting

  • Inova Schar Cancer Institute Clinical Trials

    Fairfax, Virginia, 22031

    Recruiting

  • Mercy Cancer Center

    Fort Smith, Arkansas, 72903

    Recruiting

  • Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton

    Fullerton, California, 92835

    Recruiting

  • Banner Gateway Medical Center - Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Recruiting

  • Hartford Healthcare

    Hartford, Connecticut, 06016

    Recruiting

  • Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center

    Houston, Texas, 77030

    Recruiting

  • Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

    Recruiting

  • UCI Health - Irvine

    Irvine, California, 92612

    Recruiting

  • Baptist MD Anderson Cancer Institute

    Jacksonville, Florida, 32207

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Recruiting

  • Cedars-Sinai - Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Baptist Health Medical Group Oncology

    Miami, Florida, 33176

    Recruiting

  • Mount Sinai Medical Center - Miami Beach

    Miami Beach, Florida, 33140

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Monmouth

    Middletown, New Jersey, 00748-3052

    Recruiting

  • NYU Long Island Mineola

    Mineola, New York, 11501

    Recruiting

  • Allina Health Cancer Institute - Hematology Cancer Care Services

    Minneapolis, Minnesota, 55407

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Atlantic Health - Overlook Medical Center

    Morristown, New Jersey, 07962

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Recruiting

  • Hoag Mem Hosp Presbyterian

    Newport Beach, California, 92663

    Recruiting

  • Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Recruiting

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    Orange, California, 92868-3201

    Recruiting

  • AdventHealth, Orlando

    Orlando, Florida, 32803

    Recruiting

  • AGH Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

    Recruiting

  • Oregon Health & Science University - OHSU Knight Cancer Institute

    Portland, Oregon, 97201

    Recruiting

  • Brown University Health Cancer Institute - Division of Hematology/Oncology

    Providence, Rhode Island, 02906

    Recruiting

  • University of Rochester

    Rochester, New York, 14611

    Recruiting

  • HealthPartners Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

    Recruiting

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

    Recruiting

  • Virginia Mason Franciscan Health - Virginia Mason Medical Center

    Seattle, Washington, 98101

    Recruiting

  • Fred Hutchinson Cancer Center - Advanced Cancer Research Group

    Seattle, Washington, 98109

    Recruiting

  • Mercy CH Chub O'Reilly Cancer Center

    Springfield, Missouri, 65804

    Recruiting

  • The Alvin J. Siteman Cancer Center - Center for Advanced Med

    St Louis, Missouri, 63110

    Recruiting

  • Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center

    St Louis, Missouri, 63141

    Recruiting

  • Stony Brook Medicine - Stony Brook Cancer Center

    Stony Brook, New York, 11794-9452

    Recruiting

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Recruiting

  • White Plains Hospital Center for Cancer Care - Oncology

    White Plains, New York, 10601

    Recruiting

Other trials in United States

Japan12 sites, 12 recruiting

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo

    Recruiting

  • Kyushu Group - Kyushu Cancer Center

    Fukuoka, Fukuoka

    Recruiting

  • Nara Medical University Hospital

    Kashihara-shi, Nara

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba

    Recruiting

  • Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR

    Koto, Tokyo

    Recruiting

  • Chugoku-Shikoku Group - Shikoku Cancer Center

    Matsuyama, Ehime

    Recruiting

  • Aichi Cancer Center

    Nagoya

    Recruiting

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka

    Recruiting

  • Kindai University Hospital

    Sakai, Osaka

    Recruiting

  • The University of Osaka Hospital

    Suita, Osaka

    Recruiting

  • Keio University Hospital

    Tokyo

    Recruiting

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi

    Recruiting

Other trials in Japan

France9 sites, 9 recruiting

  • Site FR33021

    Bordeaux

    Recruiting

  • Site FR33004

    Brest

    Recruiting

  • Site FR33013

    Caen

    Recruiting

  • Site FR33007

    Grenoble

    Recruiting

  • Site FR33026

    Paris

    Recruiting

  • Site FR33028

    Paris

    Recruiting

  • Site FR33034

    Toulouse

    Recruiting

  • Site FR33027

    Vandœuvre-lès-Nancy

    Recruiting

  • Site FR33022

    Villejuif

    Recruiting

Other trials in France

South Korea8 sites, 8 recruiting

  • Site KR82004

    Cheongju-si

    Recruiting

  • Site KR82015

    Incheon

    Recruiting

  • Site KR82006

    Seongnam-si

    Recruiting

  • Site KR82002

    Seoul

    Recruiting

  • Site KR82010

    Seoul

    Recruiting

  • Site KR82012

    Seoul

    Recruiting

  • Site KR82013

    Seoul

    Recruiting

  • Site KR82014

    Suwon

    Recruiting

Other trials in South Korea

United Kingdom7 sites, 7 recruiting

  • Site GB44001

    Cambridge

    Recruiting

  • Site GB44007

    Cottingham

    Recruiting

  • Site GB44010

    Ipswich

    Recruiting

  • Site GB44019

    London

    Recruiting

  • Site GB44032

    London

    Recruiting

  • Site GB44031

    Maidstone

    Recruiting

  • Site GB44020

    Sutton

    Recruiting

Other trials in United Kingdom

Spain5 sites, 5 recruiting

  • Site ES34004

    Castellon

    Recruiting

  • Site ES34023

    Lleida, Catalonia

    Recruiting

  • Site ES34007

    Málaga, Andalusia

    Recruiting

  • Site ES34001

    Pamplona, Navarra, Comunidad Foral de

    Recruiting

  • Site ES34002

    Santiago de Compostel, Galicia

    Recruiting

Other trials in Spain

Germany3 sites, 3 recruiting

  • Site DE49013

    Bochum

    Recruiting

  • Site DE49001

    Hamburg

    Recruiting

  • Site DE49020

    Münster, North Rhine-Westphalia

    Recruiting

Other trials in Germany

China2 sites, 2 recruiting

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

    Recruiting

  • Fudan University Shanghai Cancer Center - Xuhui Campus

    Shanghai, Shanghai Municipality

    Recruiting

Other trials in China

Taiwan2 sites, 2 recruiting

  • Site TW88603

    Taichung

    Recruiting

  • Site TW88605

    Taipei

    Recruiting

Other trials in Taiwan

Brazil1 site, 1 recruiting

  • Site BR55021

    São Paulo

    Recruiting

Other trials in Brazil

Poland1 site, 1 recruiting

  • Site PL48003

    Warsaw

    Recruiting

Other trials in Poland

About this study

Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX.

Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.

Read more

This study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is.

The main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy.

People in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer.

People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment.

In this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.

Being tested
Setidegrasib, Oxaliplatin, Leucovorin, Irinotecan, fluorouracil
Keywords
Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma, ASP3082, setidegrasib, KRAS G12D, PDAC, mFOLFIRINOX, NALIRIFOX
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SetidegrasibDrug

    Also called ASP3082

    Intravenous infusion

  • OxaliplatinDrug

    Intravenous infusion

  • LeucovorinDrug

    Also called folinic acid, levofolinate

    Intravenous infusion

  • IrinotecanDrug

    Intravenous infusion

  • fluorouracilDrug

    Also called 5-FU

    Intravenous infusion

  • liposomal irinotecanDrug

    Intravenous infusion

  • PlaceboDrug

    Intravenous Infusion

Study groups in NCT07409272
Study groupRoleWhat they receive
Setidegrasib plus chemotherapyExperimentalParticipants will receive setidegrasib once weekly plus mFOLFIRINOX (oxaliplatin, leucovorin [folinic acid or levofolinate], irinotecan and 5-FU) or NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin [or levofolinate] and 5 FU) chemotherapy on a 28-day cycle.
Receives: Drug: Setidegrasib; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: fluorouracil; Drug: liposomal irinotecan
Placebo plus chemotherapyPlacebo comparatorParticipants will receive placebo once weekly plus mFOLFIRINOX (oxaliplatin, leucovorin [folinic acid or levofolinate], irinotecan and 5-FU) or NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin [or levofolinate] and 5 FU) chemotherapy on a 28-day cycle.
Receives: Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: fluorouracil; Drug: liposomal irinotecan; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization until the date of death from any cause.

    Measured: Up to 3.5 years

Secondary outcomes (17)

  1. Progression-Free Survival (PFS) per RECIST v1.1. as assessed by the investigator.

    PFS is defined as the time from the start of randomization until the date of documented radiological disease progression per RECIST v1.1 as assessed by the investigator or until death for any cause, whichever comes first.

    Measured: Up to 3.5 years

  2. Time to Improvement in Pancreatic Pain (TIPP) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PAN26).

    EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.

    Measured: Up to 3.5 years

  3. Time to Worsening of General Health Status/Quality of Life (GHS/QoL) (TWGQ) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

    The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.

    Measured: Up to 3.5 years

  4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1,

    ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. as assessed by the investigator.

    Measured: Up to 3.5 years

  5. Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to 3.5 years

  6. Number of Participants with Serious Adverse Events (SAEs)

    An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.

    Measured: Up to 3.5 years

  7. Number of Participants with laboratory value abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 3.5 years

  8. Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs.

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to 3.5 years

  9. Number of Participants with vital sign abnormalities and/or AEs.

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 3.5 years

  10. Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status.

    The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

    Measured: Up to 3.5 years

  11. Pharmacokinetics (PK) of setidegrasib End-of-Infusion (EOI) concentration

    EOI Concentration will be recorded from plasma samples collected.

    Measured: Up to 9 months

  12. PK of setidegrasib in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)

    Ctrough will be recorded from plasma samples collected.

    Measured: Up to 9 months

  13. Change from baseline in EORTC QLQ-PAN26

    EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.

    Measured: Up to 3.5 years

  14. Change from baseline in EORTC QLQ-C30

    The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.

    Measured: Up to 3.5 years

  15. Change from baseline in EuroQol 5-dimensional 5-level version (EQ-5D-5L)

    The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

    Measured: Up to 3.5 years

  16. Change from baseline in Patient Global Impression of Change (PGIC).

    The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.

    Measured: Up to 3.5 years

  17. Change from baseline in Patient Global Impression of Severity PGIS

    The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.

    Measured: Up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start17 Feb 2026
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
614 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07409272
Sponsor's protocol ID
3082-CL-0301
Status last verified
Nov 2026
First submitted
9 Feb 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Setidegrasib, Oxaliplatin and Leucovorin in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Astellas Pharma Global Development, Inc. at 104 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Japan, France, South Korea, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Astellas Pharma Global Development, Inc. (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07409272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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