Lung Cancer, Nonsmall Cell Clinical Trial
— REFINE-LungOfficial title:
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) Utilising a Novel Multi-arm Frequency-response Optimisation Design
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 otherwise planning to continue therapy at 6 months will be initially randomised to control 6 weekly versus interventional 12 weekly therapy. If an interim analysis shows that the 12 weekly treatment is no less effective, subsequent patients will also be randomised to 9, 15 and 18 weekly treatment frequency arms. Patients who progress on a reduced frequency arm will be offered re-escalation to standard 6 weekly therapy.
Status | Recruiting |
Enrollment | 1750 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Bournemouth Hospital | Bournemouth | |
United Kingdom | Royal Sussex County Hospital | Brighton | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | Queen's Hospital | Burton Upon Trent | |
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
United Kingdom | East Kent Hospitals University NHS Foundation Trust | Canterbury | |
United Kingdom | Velindre Cancer Centre | Cardiff | |
United Kingdom | Colchester Hospital | Colchester | |
United Kingdom | Royal Derby Hospital | Derby | |
United Kingdom | NHS Lothian | Edinburgh | |
United Kingdom | Royal Devon and Exeter Hospital | Exeter | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
United Kingdom | New Victoria Hospital | Glasgow | |
United Kingdom | Royal Surrey NHS Foundation Trust | Guildford | |
United Kingdom | Calderdale & Huddersfield NHS Foundation Trust | Huddersfield | |
United Kingdom | Ipswich Hospital | Ipswich | |
United Kingdom | Kettering General Hospital | Kettering | |
United Kingdom | NHS Fife | Kirkcaldy | |
United Kingdom | Forth Valley Royal Hospital | Larbert | |
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | |
United Kingdom | Leicester Royal Infirmary | Leicester | |
United Kingdom | The Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | |
United Kingdom | Guys Hospital | London | |
United Kingdom | Imperial College Healthcare NHS Trust | London | |
United Kingdom | North Middlesex University Hospital NHS Trust | London | |
United Kingdom | St Bartholomew's Hospital | London | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Northampton General Hospital NHS Trust | Northampton | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
United Kingdom | Peterborough City Hospital | Peterborough | |
United Kingdom | Poole Hospital | Poole | |
United Kingdom | Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust | Romford | |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | |
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
United Kingdom | Royal Cornwall Hospital | Truro | |
United Kingdom | Worthing Hospital | Worthing | |
United Kingdom | Yeovil Hospital | Yeovil |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Medical Research Council, National Institute for Health Research, United Kingdom, University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival at 2 years | Survival at 2 years, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination | 18 months from randomisation | |
Secondary | Overall survival from study entry | Survival, defined as from commencing pembrolizumab (18 months after randomisation) to death due to any cause or study termination | 2 years | |
Secondary | Progression free survival | Progression free survival as assessed by RECIST v1.1, defined as time from study entry to first evidence of disease progression or death due to any cause | 2 years | |
Secondary | Overall response rate | Overall response rate (ORR) as assessed by RECIST v1.1, defined as complete response (CR) or partial response (PR) | 2 years | |
Secondary | Duration of response | Duration of response (DoR) as assessed by RECIST v1.1, defined as time from study entry to change in response from CR or PR to stable disease (SD) or progressive disease (PD) | 2 years | |
Secondary | Incidence of adverse events | Safety and tolerability as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 2 years |
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