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Not recruiting
Phase 3

Dato-DXd & Rilvegostomig

Sponsor:

AstraZeneca

Code:

NCT06564844

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Datopotamab Deruxtecan

Rilvegostomig

Carboplatin

Cisplatin

Etoposide

Study Details

Brief summary:

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06564844

Start date

Oct 15, 2024

Status verified date

Oct, 2025

Completion date

Jan 19, 2035

Anticipated

Primary completion date

May 19, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dato-DXd + rilvegostomig

Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).

experimental: Rilvegostomig

Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).

active comparator: Standard of Care (SoC)

Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).

Interventions

Datopotamab Deruxtecan

Datopotamab Deruxtecan IV (intravenous)

Rilvegostomig

Rilvegostomig IV (intravenous)

Carboplatin

Carboplatin IV (intravenous), Active Comparator

Cisplatin

Cisplatin IV (intravenous), Active Comparator

Etoposide

Etoposide IV (intravenous), Active Comparator

Pemetrexed

Pemetrexed IV (intravenous), Active Comparator

Vinorelbine

Vinorelbine IV (intravenous), Active Comparator

UFT

UFT Oral route of administration, Active Comparator

Primary outcome measure

  • Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC [ Time Frame: From date of randomisation up to approximately 10 years. ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

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Prescott, Arizona, United States, 86301

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Tucson, Arizona, United States, 85724

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Duarte, California, United States, 91010

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Fountain Valley, California, United States, 92708

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Glendale, California, United States, 91204

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Los Angeles, California, United States, 90089

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Newport Beach, California, United States, 92663

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Santa Barbara, California, United States, 93105

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Lone Tree, Colorado, United States, 80124

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Washington D.C., District of Columbia, United States, 20007

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Washington D.C., District of Columbia, United States, 20010

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Clermont, Florida, United States, 34711

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Fort Myers, Florida, United States, 33901

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Jacksonville, Florida, United States, 32224

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Miami, Florida, United States, 33136

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Miami Beach, Florida, United States, 33140

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Orange City, Florida, United States, 32763

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St. Petersburg, Florida, United States, 33705

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St. Petersburg, Florida, United States, 33709

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West Palm Beach, Florida, United States, 33401

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Chicago, Illinois, United States, 60637

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Evanston, Illinois, United States, 60201

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Zion, Illinois, United States, 60099

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Kansas City, Kansas, United States, 66160

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Lexington, Kentucky, United States, 40503

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Annapolis, Maryland, United States, 21401

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Baltimore, Maryland, United States, 21202

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Baltimore, Maryland, United States, 21237

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Silver Spring, Maryland, United States, 20910

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Dearborn, Michigan, United States, 48126

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Farmington Hills, Michigan, United States, 48334

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Grand Rapids, Michigan, United States, 49503

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Duluth, Minnesota, United States, 55805

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Minneapolis, Minnesota, United States, 55407

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Rochester, Minnesota, United States, 55905

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St Louis, Missouri, United States, 63108

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Billings, Montana, United States, 59102

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Omaha, Nebraska, United States, 68130

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Las Vegas, Nevada, United States, 89102

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East Syracuse, New York, United States, 13057

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Mineola, New York, United States, 11501

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New York, New York, United States, 10016

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New York, New York, United States, 10065

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The Bronx, New York, United States, 10467

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Durham, North Carolina, United States, 27710

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Cincinnati, Ohio, United States, 45219

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Cincinnati, Ohio, United States, 45245

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Cleveland, Ohio, United States, 44111

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Cleveland, Ohio, United States, 44124

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Cleveland, Ohio, United States, 44195

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Independence, Ohio, United States, 44131

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Portland, Oregon, United States, 97239

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Bethlehem, Pennsylvania, United States, 18015

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Philadelphia, Pennsylvania, United States, 19107

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Pittsburgh, Pennsylvania, United States, 15212

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Knoxville, Tennessee, United States, 37920

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Memphis, Tennessee, United States, 38120

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Nashville, Tennessee, United States, 37203

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Austin, Texas, United States, 78745

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Dallas, Texas, United States, 75231

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San Antonio, Texas, United States, 78217

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Webster, Texas, United States, 77598

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Fairfax, Virginia, United States, 22031

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Norfolk, Virginia, United States, 23502

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Edmonds, Washington, United States, 98026

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Seattle, Washington, United States, 98104

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Vancouver, Washington, United States, 98684

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Halifax, Nova Scotia, Canada, B3H 2Y9

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Oshawa, Ontario, Canada, L1G 2B9

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Greenfield Park, Quebec, Canada, J4V 2H1

Research Site

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Montreal, Quebec, Canada, H2X 3J4

More Information

Sponsor

AstraZeneca

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Non-small Cell Lung Cancer
  • NSCLC
  • Adenocarcinoma
  • Stage I
  • Datopotamab Deruxtecan
  • Dato-DXd
  • Adjuvant Treatment
  • Rilvegostomig
  • Standard of Care
  • Pemetrexed
  • Carboplatin
  • Cisplatin
  • Vinorelbine
  • Etoposide
  • UFT
  • ctDNA-positive
  • High-risk Pathological Features

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by AstraZeneca on 2025-10-14.