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Adjuvant treatment for Stage I adenocarcinoma NSCLC using Dato-DXd and rilvegostomig

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)

Phase 3 Interventional AstraZeneca · NCT06564844

This study is testing if a new combination treatment can help people with Stage I adenocarcinoma lung cancer do better after surgery compared to the usual care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment660 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations218 sites (Gilbert, Arizona and 217 other locations)
Trial IDNCT06564844 on ClinicalTrials.gov

What this trial studies

This Phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared to standard of care after complete surgical resection in patients with Stage I adenocarcinoma non-small cell lung cancer (NSCLC). Participants must be ctDNA-positive or have high-risk pathological features. The study aims to determine if this combination therapy can improve outcomes for patients who have undergone surgery. The trial includes multiple research sites across Arizona.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed Stage I adenocarcinoma NSCLC who have undergone complete surgical resection and are either ctDNA-positive or exhibit high-risk pathological features.

Not a fit: Patients with sensitizing EGFR mutations, ALK alterations, or significant pulmonary function compromise may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce the risk of recurrence in patients with high-risk Stage I adenocarcinoma NSCLC.

How similar studies have performed: Other studies have shown promising results with similar adjuvant therapies in NSCLC, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gilbert, Arizona and 217 other locations

+168 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerNSCLCAdenocarcinomaStage IDatopotamab DeruxtecanDato-DXdAdjuvant TreatmentRilvegostomig
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.