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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Barretos, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Datopotamab deruxtecan

Drug

Datopotamab Deruxtecan IV (intravenous)

Other names: Dato-DXd, DS-1062a

Rilvegostomig

Drug

Rilvegostomig IV (intravenous)

Other names: AZD2936

carboplatin

Drug

Carboplatin IV (intravenous), Active Comparator

Cisplatin

Drug

Cisplatin IV (intravenous), Active Comparator

etoposide

Drug

Etoposide IV (intravenous), Active Comparator

Pemetrexed

Drug

Pemetrexed IV (intravenous), Active Comparator

Vinorelbine

Drug

Vinorelbine IV (intravenous), Active Comparator

UFT

Drug

UFT Oral route of administration, Active Comparator

Primary outcomes

  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

    Time frame: From date of randomisation up to approximately 10 years.

    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.

Secondary outcomes

  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

    Time frame: From date of randomisation up to approximately 10 years.

    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.

  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

    Time frame: Measured at weeks 12, 24 and 48.

    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.

  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

    Time frame: Measured at weeks 12, 24 and 48.

    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.

  4. Pharmacokinetics (PK)

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

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

  5. Pharmacokinetics (PK)

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

    Concentration of rilvegostomig in plasma or serum.

  6. Pharmacokinetics (PK)

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

    PK parameters (peak and through concentrations).

  7. Immunogenicity

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

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study 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)

Acronym: TROPION-Lung12

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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