Datopotamab Deruxtecan + Immunotherapy for Non-Small Cell Lung Cancer
(TROPION-Lung04 Trial)
Trial Summary
What is the purpose of this trial?
This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of Datopotamab Deruxtecan and Durvalumab safe for humans?
What makes the drug Datopotamab Deruxtecan + Durvalumab unique for non-small cell lung cancer?
Research Team
Global Clinical Leader
Principal Investigator
Daiichi Sankyo, Inc.
Eligibility Criteria
Adults with advanced or metastatic non-small cell lung cancer (NSCLC) who are either treatment-naïve or have had one prior chemotherapy without immune checkpoint inhibitors. Participants must have good organ function, measurable disease, no severe illnesses, and an ECOG performance status of 0 or 1. Those with certain genetic alterations in NSCLC or a history of other cancers are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dato-DXd in combination with immunotherapy with or without carboplatin. Part 1 involves dose escalation or confirmation, and Part 2 involves dose expansion.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of disease control rate and pharmacokinetic parameters.
Long-term follow-up
Participants are monitored for overall survival and other secondary outcomes.
Treatment Details
Interventions
- Carboplatin
- Datopotamab deruxtecan
- Durvalumab
Datopotamab deruxtecan is already approved in Japan for the following indications:
- HER2-negative breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Daiichi Sankyo, Inc.
Industry Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University