Clinical Trial: NCT04686305
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-04-13 |
Study Overview
Brief 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.
Official Title
A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)
Conditions
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: T-DXd
- Biological: Durvalumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Volrustomig
- Drug: Rilvegostomig
Other Study ID Numbers
- D967YC00001
- 2023-504949-31-00
- 2020-003260-31
- 2023
Start Date (Actual)
2021-03-09
Primary Completion Date (Estimated)
2027-06-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
304
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-04-13 |
Study Overview
Brief 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.
Official Title
A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)
Conditions
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: T-DXd
- Biological: Durvalumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Volrustomig
- Drug: Rilvegostomig
Other Study ID Numbers
- D967YC00001
- 2023-504949-31-00
- 2020-003260-31
- 2023
Start Date (Actual)
2021-03-09
Primary Completion Date (Estimated)
2027-06-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
304
Study Type
Interventional
Phase
Phase 1