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New hope for early lung cancer: targeted combo aims to stop return after surgery

NCT ID NCT06564844

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether adding two new drugs (datopotamab deruxtecan and rilvegostomig) after surgery can help prevent early-stage lung cancer from coming back. It is for people with stage I adenocarcinoma non-small cell lung cancer who have signs of cancer DNA in their blood or other high-risk features. Participants will receive either the drug combination, rilvegostomig alone, or standard care, and researchers will compare how long they stay cancer-free.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenocarcinoma lung adenocarcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85724, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Glendale, California, 91204, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Lone Tree, Colorado, 80124, United States

  • Research Site

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

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    St. Petersburg, Florida, 33709, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Evanston, Illinois, 60201, United States

  • Research Site

    Zion, Illinois, 60099, United States

  • Research Site

    Kansas City, Kansas, 66160, United States

  • Research Site

    Lexington, Kentucky, 40503, United States

  • Research Site

    Baltimore, Maryland, 21237, United States

  • Research Site

    Farmington Hills, Michigan, 48334, United States

  • Research Site

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    Minneapolis, Minnesota, 55407, United States

  • Research Site

    Billings, Montana, 59102, United States

  • Research Site

    Omaha, Nebraska, 68130, United States

  • Research Site

    East Syracuse, New York, 13057, United States

  • Research Site

    Mineola, New York, 11501, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    Bethlehem, Pennsylvania, 18015, United States

  • Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    Knoxville, Tennessee, 37920, United States

  • Research Site

    Memphis, Tennessee, 38120, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Austin, Texas, 78745, United States

  • Research Site

    Dallas, Texas, 75231, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78217, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Seattle, Washington, 98104, United States

  • Research Site

    Madison, Wisconsin, 53792, United States

  • Research Site

    Barretos, 14784-057, Brazil

  • Research Site

    Brasília, 70200-730, Brazil

  • Research Site

    Florianópolis, 88034-000, Brazil

  • Research Site

    São Paulo, 01323-903, Brazil

  • Research Site

    Teresina, 64049-200, Brazil

  • Research Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Research Site

    Oshawa, Ontario, L1G 2B9, Canada

  • Research Site

    Montreal, Quebec, H2X 3J4, Canada

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Chiba, 260-0877, Japan

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hidaka-shi, 350-1298, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Iwakuni-shi, 740-8510, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    Kobe, 650-0017, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kumamoto, 860-8556, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Sendai, 980-0873, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Kuala Lumpur, 50586, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkoknoi, 10700, Thailand

  • Research Site

    Banphaeo, 74120, Thailand

  • Research Site

    Dusit, 10300, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Muang, 40002, Thailand

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Ratchathewi, 10400, Thailand

  • Research Site

    Ankara, 06010, Turkey (Türkiye)

  • Research Site

    Ankara, 06280, Turkey (Türkiye)

  • Research Site

    Mersin, 33240, Turkey (Türkiye)

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Vinh, 460000, Vietnam

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