Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Phase 1 Recruiting 304 enrolled AstraZeneca Daiichi Sankyo · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Timeline

Start: 2021-03-09
Primary completion: 2027-06-30
Completion: 2027-06-30

Publications

Planchard D, Kim HR, Suksombooncharoen T, Li R, Cortinovis D, Han JY, Samol J, Runglodvatana Y, Lee KY, Chang GC, Lee CH, Kowalski D, Saw SPL, Huang Y, Ruiter G, Ahn MJ, Yang TY, Yang CT, Sookprasert A, Nakajima EC, Alfon J, McEwen R, Chang YT, Yang JC. Trastuzumab Deruxtecan in Patients With HER2-Overexpressing NSCLC: Results From Part 1 of the Open-Label, Multicenter, Phase 1b DESTINY-Lung03 Trial. J Thorac Oncol. 2026 May;21(5):103541. doi: 10.1016/j.jtho.2025.12.080. Epub 2025 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cisplatin	Other / unclassified	60 mg/m2	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Durvalumab	Monoclonal antibody	1120 mg	Intravenous
Subject	Rilvegostomig	Other / unclassified	—	Intravenous
Subject	T-DXd	Unknown	4.4 mg/kg	Intravenous
Subject	T-DXd	Unknown	5.4 mg/kg	Intravenous
Subject	Volrustomig	Monoclonal antibody	—	Intravenous
Background	Pemetrexed	Small molecule	—	Intravenous

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Summary

Timeline

Publications

Drugs

Indications