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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06564844

This Phase III study evaluates the efficacy and safety of adjuvant Dato-DXd with rilvegostomig versus standard care in Stage I adenocarcinoma NSCLC patients post-surgery. Eligible participants are ctDNA-positive or have high-risk features. Interventions include Datopotamab Deruxtecan, Rilvegostomig, and various active comparators like Carboplatin and Cisplatin. Participants must have adequate organ function and recovery post-surgery.

Patient Parameters

Program Overview

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.

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.

Eligibility 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

Locations

FACILITYZIPCITYSTATE
Research Site85234GilbertArizona
Research Site85054PhoenixArizona
Research Site85710TucsonArizona
Research Site85719TucsonArizona
Research Site91010DuarteCalifornia
Research Site92708Fountain ValleyCalifornia
Research Site91204GlendaleCalifornia
Research Site90033Los AngelesCalifornia
Research Site90095Los AngelesCalifornia
Research Site92868OrangeCalifornia

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