Status:
RECRUITING
A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Medical Research Council
Conditions:
Lung Cancer, Nonsmall Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
REFINE-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective. Patients treated with 1st line pembrolizumab who are progression free and...
Detailed Description
Immunotherapy with pembrolizumab targeting the T cell inhibitory PD-1 receptor has significantly improved outcomes in advanced non-small cell lung cancer (NSCLC). Approximately 3600 new patients are t...
Eligibility Criteria
Inclusion
- Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule
- Any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced Non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit.
Exclusion
- Disease progression or not tolerating treatment at 6 months into therapy
- Clinician does not intend to continue immunotherapy
- Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment.
- Any patient currently receiving an investigational agent and/or using an investigational device or has participated in a study of an investigational agent and/or used an investigational device within 28 days of randomisation.
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
1750 Patients enrolled
Trial Details
Trial ID
NCT05085028
Start Date
June 23 2022
End Date
May 31 2027
Last Update
March 7 2024
Active Locations (37)
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1
Royal Bournemouth Hospital
Bournemouth, United Kingdom
2
Royal Sussex County Hospital
Brighton, United Kingdom
3
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
4
Queen's Hospital
Burton-on-Trent, United Kingdom