SOLAR Study
Research type
Research Study
Full title
An Open-label, Randomised Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumours with EGFR Activating Mutations
IRAS ID
188506
Contact name
Minal Kara
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2015-002894-39
Clinicaltrials.gov Identifier
119,902, IND
Duration of Study in the UK
2 years, 10 months, 27 days
Research summary
Lung cancer is a leading cause of cancer death worldwide. Lung cancer accounts for over 1 million mortalities annually and Non-Small Cell Lung Cancer (NSCLC) accounts for almost 85% of all cases.
Early clinical data suggest that ASP8273 (the study drug) may provide benefit to participants with locally advanced or metastatic NSCLC with an Epidermal Growth Factor Receptor (EGFR; a protein receptor that is responsive for active tumour growth) activation mutation. ASP8273 is a molecule that inhibits EGFR activity and is thought to prolong progression free survival (PFS; the time that passes from the first day of treatment patient is enrolled on the study, and the date on which disease "progresses" or the date on which the patient dies, from any cause).
The aim of the study is to collect information to determine if ASP8273 is effective and safe in EGFR mutated NSCLC population. The study is designed to prove the assumption of improvement in median PFS by 5 months with ASP8273 compared to the current standard of care or approved treatments such as erlotinib or gefitinib.
This is an open label study meaning that both the participant and the study doctor will know which medication is being given. The study is randomised, meaning that participants will be randomly assigned 1:1 to receive either ASP8273 or current standard of care treatment.
Astellas Pharma Global Development Inc is the sponsor of this study which will take place across Europe, Asia, and North and South America. It is anticipated that approximately 540 participants will be recruited worldwide.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0028
Date of REC Opinion
11 Mar 2016
REC opinion
Further Information Favourable Opinion