Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations - AVANZAR

Study identifier:D926NC00001

ClinicalTrials.gov identifier:NCT05687266

EudraCT identifier:2021-004606-21

CTIS identifier:N/A

Recruiting

Official Title

A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

Medical condition

NSCLC

Phase

Phase 3

Healthy volunteers

No

Study drug

Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin, Pemetrexed, Paclitaxel

Sex

All

Estimated Enrollment

1280

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Dec 2022
Estimated Primary Completion Date: 22 Feb 2027
Estimated Study Completion Date: 22 Feb 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria