Study of DS-1062a with or without Pembrolizumab in Advanced or Metastatic Non-small Cell Lung Cancer
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)
IRAS ID
1004940
Contact name
Eric Richards
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2021-002555-10
ISRCTN Number
ISRCTN24189848
Research summary
Lung cancer is the most common cancer and the leading cause of cancer-related mortality worldwide, with an estimated 2.2 million new cases of lung cancer in 2020 (11.4% of all new cases) and 1.8 million deaths (18.0% of all cancer deaths) globally, based on GLOBOCAN data. Advances in the early detection of lung cancer have been slow, and more than half of lung cancers are still diagnosed at an advanced stage. Only 18.6% of all patients with lung cancer are alive 5 years or more after diagnosis. Non-small-cell lung cancer (NSCLC) accounts for 80% to 85% of all lung cancers.
The introduction of immunotherapy to treat metastatic NSCLC has significantly improved patients’ prognosis.
This Phase 3 study, Tropion-Lung08 (DS1062-A-U304), is designed to assess the efficacy and safety of Dato-DXd (investigational drug) when added to pembrolizumab versus pembrolizumab alone, as the first-line treatment of advanced or metastatic NSCLC.
Dato-DXd demonstrated encouraging antitumour activity and a manageable safety profile in heavily pretreated subjects with NSCLC in the Tropion-PanTumor01 Phase 1, first-in-human study of Dato-DXd in participants with advanced solid tumours.
Adults aged 18 years or over with NSCLC, and who meet the eligibility criteria, will be invited to take part in this study. Approximately 740 eligible participants will be randomised in a 1:1 ratio to receive either Dato-Dxd plus pembrolizumab, or pembrolizumab alone.
Participation in the treatment phase of the study can last up to two years. Once the participant’s treatment under the study has ended, they will enter a long term follow up period, where their general health will be checked every three months.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0067
Date of REC Opinion
13 May 2022
REC opinion
Further Information Favourable Opinion