Phase 1b Study of Dato-DXd in Combination with Immunotherapy with or without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer - TROPION-Lung04

Study identifier:D926FC00001

ClinicalTrials.gov identifier:NCT04612751

EudraCT identifier:2021-000274-28

CTIS identifier:N/A

Recruiting

Official Title

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

Medical condition

Advanced or Metastatic NSCLC

Phase

Phase 1

Healthy volunteers

No

Study drug

Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Carboplatin, Carboplatin, Carboplatin, Carboplatin, Carboplatin, Carboplatin, AZD2936, AZD2936, AZD2936, AZD2936, MEDI5752, MEDI5752, MEDI5752

Sex

All

Actual enrollment

232

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 02 Feb 2021
Estimated Primary Completion Date: 28 Feb 2025
Estimated Study Completion Date: 28 Feb 2025

Study design

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

Verification:

Verified 01 May 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria