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

Trial Title: 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

NCT ID: NCT06564844

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carboplatin
Etoposide
Pemetrexed
Vinorelbine

Conditions: 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

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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)).

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: Open-label, sponsor-blinded

Intervention:

Intervention type: Drug
Intervention name: Datopotamab Deruxtecan
Description: Datopotamab Deruxtecan IV (intravenous)
Arm group label: Dato-DXd + rilvegostomig

Other name: Dato-DXd, DS-1062a

Intervention type: Drug
Intervention name: Rilvegostomig
Description: Rilvegostomig IV (intravenous)
Arm group label: Dato-DXd + rilvegostomig
Arm group label: Rilvegostomig

Other name: AZD2936

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin IV (intravenous), Active Comparator
Arm group label: Standard of Care (SoC)

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin IV (intravenous), Active Comparator
Arm group label: Standard of Care (SoC)

Intervention type: Drug
Intervention name: Etoposide
Description: Etoposide IV (intravenous), Active Comparator
Arm group label: Standard of Care (SoC)

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed IV (intravenous), Active Comparator
Arm group label: Standard of Care (SoC)

Intervention type: Drug
Intervention name: Vinorelbine
Description: Vinorelbine IV (intravenous), Active Comparator
Arm group label: Standard of Care (SoC)

Intervention type: Drug
Intervention name: UFT
Description: UFT Oral route of administration, Active Comparator
Arm group label: Standard of Care (SoC)

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.

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

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Start date: October 28, 2024

Completion date: February 1, 2035

Lead sponsor:
Agency: AstraZeneca
Agency class: Industry

Collaborator:
Agency: Daiichi Sankyo
Agency class: Industry

Source: AstraZeneca

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06564844