Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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)

Details

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.

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, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Dato-DXd + rilvegostomig

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Los Angeles California 90033 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06564844
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 660 study participants
Last Updated