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Non-small Cell Lung CancerPhase 3TROPION-Lung12NCT06564844

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

A Phase 3 study testing Datopotamab Deruxtecan, Rilvegostomig and Carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 90 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Datopotamab Deruxtecan, Rilvegostomig and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
90 sitesin 10 countries
Study dates
15 Oct 2024to 31 Mar 2027
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

  • Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
  • Complete surgical resection (R0) of the primary NSCLC
  • Unequivocal no evidence of disease at post-surgical
  • 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)
  • ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery
  • Adequate bone marrow reserve and organ function

Who cannot join

  • Sensitizing EGFR mutation and/or ALK alteration
  • 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
  • Significant pulmonary function compromise
  • History of another primary malignancy within 3 years (with exceptions)
  • Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
  • Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Show all 9Show fewer
  • Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
  • History of active primary immunodeficiency
  • Clinically significant corneal disease

Trial locations and contacts

90 sites in 10 countries.

90 sites in 10 countries

United States37 sites

  • Research Site

    Austin, Texas, 78745

  • Research Site

    Baltimore, Maryland, 21237

  • Research Site

    Bethlehem, Pennsylvania, 18015

  • Research Site

    Billings, Montana, 59102

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Dallas, Texas, 75231

  • Research Site

    Duarte, California, 91010

  • Research Site

    East Syracuse, New York, 13057

  • Research Site

    Evanston, Illinois, 60201

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Farmington Hills, Michigan, 48334

  • Research Site

    Glendale, California, 91204

  • Research Site

    Grand Rapids, Michigan, 49503

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Knoxville, Tennessee, 37920

  • Research Site

    Lexington, Kentucky, 40503

  • Research Site

    Lone Tree, Colorado, 80124

  • Research Site

    Los Angeles, California, 90089

  • Research Site

    Madison, Wisconsin, 53792

  • Research Site

    Memphis, Tennessee, 38120

  • Research Site

    Mineola, New York, 11501

  • Research Site

    Minneapolis, Minnesota, 55407

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    New York, New York, 10016

  • Research Site

    New York, New York, 10065

  • Research Site

    Omaha, Nebraska, 68130

  • Research Site

    Philadelphia, Pennsylvania, 19107

  • Research Site

    Pittsburgh, Pennsylvania, 15212

  • Research Site

    Portland, Oregon, 97239

  • Research Site

    San Antonio, Texas, 78217

  • Research Site

    Seattle, Washington, 98104

  • Research Site

    St. Petersburg, Florida, 33709

  • Research Site

    Tucson, Arizona, 85724

  • Research Site

    Washington D.C., District of Columbia, 20007

  • Research Site

    Zion, Illinois, 60099

Other trials in United States

Japan21 sites

  • Research Site

    Bunkyō City, 113-8603

  • Research Site

    Chiba, 260-0877

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Fukuoka, 812-8582

  • Research Site

    Hidaka-shi, 350-1298

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Iwakuni-shi, 740-8510

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kitaadachi-gun, 362-0806

  • Research Site

    Kobe, 650-0017

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Kumamoto, 860-8556

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Niigata, 951-8566

  • Research Site

    Osakasayama-shi, 589-8511

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Sendai, 980-0873

  • Research Site

    Sendai, 980-8574

  • Research Site

    Wakayama, 641-8510

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Thailand8 sites

  • Research Site

    Bangkok, 10400

  • Research Site

    Bangkoknoi, 10700

  • Research Site

    Banphaeo, 74120

  • Research Site

    Dusit, 10300

  • Research Site

    Hat Yai, 90110

  • Research Site

    Muang, 40002

  • Research Site

    Muang, 50200

  • Research Site

    Ratchathewi, 10400

Other trials in Thailand

Brazil5 sites

  • Research Site

    Barretos, 14784-057

  • Research Site

    Brasília, 70200-730

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    São Paulo, 01323-903

  • Research Site

    Teresina, 64049-200

Other trials in Brazil

Taiwan5 sites

  • Research Site

    Kaohsiung City, 80756

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 112

  • Research Site

    Taipei, 114

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Vietnam4 sites

  • Research Site

    Hà Nội, 100000

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Vinh, 460000

Other trials in Vietnam

Canada3 sites

  • Research Site

    Halifax, Nova Scotia, B3H 2Y9

  • Research Site

    Montreal, Quebec, H2X 3J4

  • Research Site

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

Malaysia3 sites

  • Research Site

    Kuala Lumpur, 50586

  • Research Site

    Kuala Lumpur, 59100

  • Research Site

    Kuching, 93586

Other trials in Malaysia

Turkey (Türkiye)3 sites

  • Research Site

    Ankara, 06010

  • Research Site

    Ankara, 06280

  • Research Site

    Mersin, 33240

Other trials in Turkey (Türkiye)

Hong Kong1 site

  • Research Site

    Hong Kong, 999077

Other trials in Hong Kong

About this study

Official title: A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

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.

Read the detailed description

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to 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.

Being tested
Datopotamab Deruxtecan, Rilvegostomig, Carboplatin, Cisplatin, Etoposide
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

What participants receive

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

  • Datopotamab DeruxtecanDrug

    Also called Dato-DXd, DS-1062a

    Datopotamab Deruxtecan IV (intravenous)

  • RilvegostomigDrug

    Also called AZD2936

    Rilvegostomig IV (intravenous)

  • CarboplatinDrug

    Carboplatin IV (intravenous), Active Comparator

  • CisplatinDrug

    Cisplatin IV (intravenous), Active Comparator

  • EtoposideDrug

    Etoposide IV (intravenous), Active Comparator

  • PemetrexedDrug

    Pemetrexed IV (intravenous), Active Comparator

  • VinorelbineDrug

    Vinorelbine IV (intravenous), Active Comparator

  • UFTDrug

    UFT Oral route of administration, Active Comparator

Study groups in NCT06564844
Study groupRoleWhat they receive
Dato-DXd + rilvegostomigExperimentalParticipants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Receives: Drug: Datopotamab Deruxtecan; Drug: Rilvegostomig
RilvegostomigExperimentalParticipants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Receives: Drug: Rilvegostomig
Standard of Care (SoC)Active comparatorPatients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Pemetrexed; Drug: Vinorelbine; Drug: UFT

What is being measured

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

  1. 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

    The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy.

    The measure of interest is the HR of DFS.

    Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.

    Measured: From date of randomisation up to approximately 10 years.

Secondary outcomes (7)

  1. Overall Survival (OS) 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

    The analysis will include all randomised participants as randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy.

    The measure of interest is the HR of OS.

    Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.

    Measured: From date of randomisation up to approximately 10 years.

  2. Participant-reported physical function 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

    The analysis will include all randomised participants as randomised. The physical function will be measured by the PROMIS SF PF 8c. Data from PROMIS SF PF 8c will capture participants' perceived ability to perform specific activities from daily life and will be scored on a 5-point rating scale.

    The measure of interest will be the between treatment group difference in adjusted mean in physical function scores.

    Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.

    Measured: Measured at weeks 12, 24 and 48.

  3. Participant-reported GHS/QoL 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

    The analysis will include all randomised participants as randomised. The GHS/QoL scores will be measured by the GHS/QoL scale from EORTC IL172.

    The measure of interest will be the between treatment group difference in adjusted mean in GHS/QoL scores.

    Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.

    Measured: Measured at weeks 12, 24 and 48.

  4. Pharmacokinetics (PK)

    Concentration of Dato-DXd, total anti-TROP2 antibody, and MAAA-1181a (payload deruxtecan) in plasma or serum.

    Measured: Up to 30 or 90 days post-last dose of study intervention.

  5. Pharmacokinetics (PK)

    Concentration of rilvegostomig in plasma or serum.

    Measured: Up to 30 or 90 days post-last dose of study intervention.

  6. Pharmacokinetics (PK)

    PK parameters (peak and through concentrations).

    Measured: Up to 30 or 90 days post-last dose of study intervention.

  7. Immunogenicity

    Presence of ADAs for Dato-DXd and rilvegostomig (confirmatory results: titres and neutralising antibodies for confirmed positive samples).

    Measured: Up to 30 or 90 days post-last dose of study intervention.

Timeline

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

  1. First posted21 Aug 2024
  2. Study start15 Oct 2024
  3. Primary completion10 Jul 2026
  4. Study completion31 Mar 2027 (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
Model description
Participants will be randomised in a 2:1:2 ratio to one of the following groups: Arm 1 - Dato-DXd in combination with rilvegostomig, Arm 2 - rilvegostomig monotherapy or Arm 3 - SoC (either observation only or investigator's choice of chemotherapy (ICC)).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564844
Sponsor's protocol ID
D926TC00001
Other IDs
2024-512195-35-00
Acronym
TROPION-Lung12
Status last verified
Sep 2026
First submitted
7 Aug 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Publications

  • Jones DR, Opitz I, Harpole D, Yanagawa J, Lim E, Tsutani Y, Tan DSW, Dacic S, Ganti AK, Bodla S, Batig A, Lyfar P, Forcina A, Felip E. TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2026 Jan;171(1):1-9. doi: 10.1016/j.jtcvs.2025.09.017. Epub 2025 Sep 19.

    PubMed 40976544

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Datopotamab Deruxtecan, Rilvegostomig and Carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 90 sites in 10 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 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Japan, Thailand, Brazil, Taiwan and 5 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). 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 NCT06564844, which also lists 1 linked publication.

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 23 Sep 2026.

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