TROPION-LUNG01
Research type
Research Study
Full title
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer without Actionable Genomic Alterations
IRAS ID
292506
Contact name
Fabio Gomes
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2020-004643-80
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 136626
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
This is a global, multicentre, randomised, active-controlled, open-label phase 3 study of Ds-1062a versus Docetaxel in previously treated advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) without Actionable Genomic Alterations. This is a global study at approximately 175 study sites located predominantly in North America, South America, Europe, and Asia Pacific region. Patients with advanced or metastatic NSCLC without actionable genomic alterations (i.e. alterations in genes with approved therapies), and who have been previously treated with platinum-based chemotherapy are eligible to participate in this study.
The primary objective of this study is to compare the efficacy of DS-1062a with that of docetaxel, as measured by progression-free survival (PFS) and overall survival (OS).
Eligible participants will be randomised in a 1:1 ratio to DS-1062a 6.0 mg/kg or the control treatment docetaxel 75 mg/m2. No crossover between any study treatment arms will be allowed. The study plans to have about 590 participants take part. The study will be divided into 3 periods, screening, treatment and follow-up period (which includes the Long-term Survival Follow-up). Participants will receive 3 cycle of treatment, each cycle is of 21 days. Participants will be in the study for approximately 4 months.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0038
Date of REC Opinion
13 Apr 2021
REC opinion
Further Information Favourable Opinion