A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
Launched by ASTRAZENECA · Aug 19, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment approach for patients with Stage I adenocarcinoma non-small cell lung cancer (NSCLC) who have had their tumors completely removed through surgery. The study is comparing the effects of a combination of two medications, Dato-DXd and rilvegostomig, against the usual standard of care after surgery. Researchers are particularly interested in patients who have a specific genetic marker called ctDNA, which suggests a higher risk of cancer returning, or those who show other high-risk features after surgery.
To be eligible for this trial, participants must have been diagnosed with Stage I adenocarcinoma NSCLC, have successfully undergone complete surgical removal of their cancer, and have no evidence of disease after surgery. They should also have either tested positive for ctDNA or have certain high-risk characteristics of their cancer. Participants will receive close monitoring throughout the study, and the trial is currently accepting patients aged 65 to 74, regardless of gender. This trial aims to determine if the new combination treatment can improve outcomes for these patients and provide more effective care following surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
- • 2. Complete surgical resection (R0) of the primary NSCLC
- • 3. Unequivocal no evidence of disease at post-surgical
- • 4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
- • 5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
- • 6. Adequate bone marrow reserve and organ function
- Exclusion Criteria:
- • 1. Sensitizing EGFR mutation and/or ALK alteration
- • 2. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- • 3. Significant pulmonary function compromise
- • 4. History of another primary malignancy within 3 years (with exceptions)
- • 5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
- • 6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- • 7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
- • 8. History of active primary immunodeficiency
- • 9. Clinically significant corneal disease
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Rochester, Minnesota, United States
Durham, North Carolina, United States
Houston, Texas, United States
Cleveland, Ohio, United States
Fairfax, Virginia, United States
Nashville, Tennessee, United States
Fountain Valley, California, United States
Memphis, Tennessee, United States
Norfolk, Virginia, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Edegem, , Belgium
Hasselt, , Belgium
Madrid, , Spain
Aurora, Colorado, United States
Portland, Oregon, United States
Madison, Wisconsin, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Bethlehem, Pennsylvania, United States
Seattle, Washington, United States
Zaragoza, , Spain
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Santa Barbara, California, United States
Zion, Illinois, United States
Padova, , Italy
Roma, , Italy
Zurich, , Switzerland
Evanston, Illinois, United States
Bronx, New York, United States
Miami, Florida, United States
Philadelphia, Pennsylvania, United States
Miami Beach, Florida, United States
Greenfield Park, Quebec, Canada
Rotterdam, , Netherlands
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Madrid, , Spain
Los Angeles, California, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Worcester, Massachusetts, United States
Farmington Hills, Michigan, United States
Pittsburgh, Pennsylvania, United States
Orange, California, United States
London, , United Kingdom
Oshawa, Ontario, Canada
Debrecen, , Hungary
Saint Petersburg, Florida, United States
Annapolis, Maryland, United States
Grand Rapids, Michigan, United States
Duluth, Minnesota, United States
Saint Paul, Minnesota, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
St. John's, Newfoundland And Labrador, Canada
Leeds, , United Kingdom
Ann Arbor, Michigan, United States
San Diego, California, United States
Omaha, Nebraska, United States
Boston, Massachusetts, United States
Mineola, New York, United States
New York, New York, United States
Tucson, Arizona, United States
Duarte, California, United States
Newark, Delaware, United States
Boston, Massachusetts, United States
Billings, Montana, United States
Angers, , France
Lexington, Kentucky, United States
Firenze, , Italy
Paris Cedex 5, , France
Nottingham, , United Kingdom
Roma, , Italy
Glendale, California, United States
Troy, Michigan, United States
Austin, Texas, United States
Vancouver, Washington, United States
Giessen, , Germany
Taipei, , Taiwan
Bangkok, , Thailand
Törökbálint, , Hungary
Camden, New Jersey, United States
West Palm Beach, Florida, United States
Orange City, Florida, United States
Barcelona, , Spain
Jacksonville, Florida, United States
Montreal, Quebec, Canada
Gilbert, Arizona, United States
Fort Myers, Florida, United States
Knoxville, Tennessee, United States
Webster, Texas, United States
Olsztyn, , Poland
Rozzano, , Italy
Halifax, Nova Scotia, Canada
Silver Spring, Maryland, United States
Prescott, Arizona, United States
Fort Wayne, Indiana, United States
Seoul, , Korea, Republic Of
Newport Beach, California, United States
Boise, Idaho, United States
Frederick, Maryland, United States
Las Vegas, Nevada, United States
East Syracuse, New York, United States
Allentown, Pennsylvania, United States
Silverdale, Washington, United States
Hiroshima Shi, , Japan
Nagoya Shi, , Japan
Niigata Shi, , Japan
Sapporo Shi, , Japan
Taipei, , Taiwan
Chuo Ku, , Japan
Pécs, , Hungary
Kuching, , Malaysia
Kaohsiung, , Taiwan
Kashiwa, , Japan
Koto Ku, , Japan
Bonn, , Germany
Essen, , Germany
Ypsilanti, Michigan, United States
Barcelona, , Spain
Würzburg, , Germany
Kumamoto Shi, , Japan
Royal Oak, Michigan, United States
Gauting, , Germany
Lone Tree, Colorado, United States
Rouen, , France
Saint Petersburg, Florida, United States
Seoul, , Korea, Republic Of
Muang, , Thailand
Ratchathewi, , Thailand
Hanoi, , Vietnam
Alicante, , Spain
Bangkoknoi, , Thailand
Ho Chi Minh, , Vietnam
Esslingen, , Germany
Karlsruhe, , Germany
Erfurt, , Germany
London, , United Kingdom
Solna, , Sweden
Kitaadachi Gun, , Japan
Yokohama Shi, , Japan
Taoyuan, , Taiwan
Newmarket, Ontario, Canada
Iwakuni Shi, , Japan
Hat Yai, , Thailand
Incheon, , Korea, Republic Of
White Plains, New York, United States
Gera, , Germany
Hidaka Shi, , Japan
Budapest, , Hungary
Bunkyo Ku, , Japan
Sendai Shi, , Japan
Wakayama Shi, , Japan
Suwon, , Korea, Republic Of
Hiroshima Shi, , Japan
Poznań, , Poland
Marseille, , France
Warszawa, , Poland
Ha Noi, , Vietnam
Los Angeles, California, United States
Fukuoka Shi, , Japan
Osakasayama Shi, , Japan
Zalaegerszeg, , Hungary
Kobe Shi, , Japan
Clermont, Florida, United States
Florianópolis, , Brazil
Badalona, , Spain
Seattle, Washington, United States
Sao Paulo, , Brazil
George Town, , Malaysia
Kuala Lumpur, , Malaysia
Suresnes, , France
Georgsmarienhütte, , Germany
Kempten, , Germany
Teresina, , Brazil
Jordan, , Hong Kong
Istanbul, , Turkey
Malaga, , Spain
Selangor, , Malaysia
Chiba Shi, , Japan
Toulon, , France
Ankara, , Turkey
Brasília, , Brazil
Luebeck, , Germany
Dusit, , Thailand
Monza, , Italy
Dyer, Indiana, United States
Da Nang, , Vietnam
Münster, , Germany
Dearborn, Michigan, United States
Vinh, , Vietnam
Hong Kong, , Hong Kong
Independence, Ohio, United States
Dallas, Texas, United States
Banphaeo, , Thailand
Phoenix, Arizona, United States
Barretos, , Brazil
Mersin, , Turkey
Jordan, , Hong Kong
Patients applied
Trial Officials
David Jones, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center, New York, United States of America
Enriqueta Felip, MD
Principal Investigator
Vall d'Hebron Hospital, Barcelona, Spain
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported