DS8201-793 DESTINY-Lung06
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)
IRAS ID
1012232
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo, Inc
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn more about a drug called Trastuzumab Deruxtecan (T-DXd) in combination with immunotherapy (pembrolizumab) in those with a diagnosis of non-squamous locally advanced unresectable or metastatic non-small Cell Lung Cancer (NSCLC). It is being studied to see if it is safe, and if participant's disease or medical condition improves while taking it.
T-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumour cells to deliver chemotherapy directly to tumour cells while sparing healthy cells. T-DXd, as an ADC, is made up of 2 parts: an anticancer drug and an antibody (type of protein). The antibody part binds to cancer cells that have the human epidermal growth factor receptor 2 (HER2) receptor. Receptors are protein molecules on the surface of cells that can receive a chemical signal. When the antibody binds to the HER2 receptor in the cancer cell surface, it delivers the anticancer drug into the cancer cell. Pembrolizumab targets a protein called programmed cell death protein 1 (PD-1), which engages the immune system to target cancer cells.
While T-DXd (ENHERTU®) is approved for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation (genetic changes, causing excessive cell growth and division) and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. T-DXd (ENHERTU®) has not been approved for HER2-overexpressing NSCLC. In addition, pembrolizumab alone is approved for the first-line treatment of metastatic non-small cell lung carcinoma.
T-DXd with pembrolizumab is being compared to the standard treatment of platinum-based chemotherapy with pembrolizumab, by measuring how long patients live without their cancer getting worse.
Approximately 686 participants will be enrolled in this study. The total duration of this study will be approximately 7 years.REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0543
Date of REC Opinion
9 Sep 2025
REC opinion
Further Information Favourable Opinion