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Search / Trial NCT06564844

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 23, 2025

Recruiting

Keywords

Non Small Cell Lung Cancer Nsclc Adenocarcinoma Stage I Datopotamab Deruxtecan Dato D Xd Adjuvant Treatment Rilvegostomig Standard Of Care Pemetrexed Carboplatin Cisplatin Vinorelbine Etoposide Uft Ct Dna Positive High Risk Pathological Features

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.

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

0 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