ISRCTN70247820

Reduced frequency pembrolizumab immunotherapy: can the frequency of pembrolizumab treatment for non-small cell lung cancer be reduced without reducing its effectiveness?

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
Imperial College London·Phase 3·ISRCTN Registry·drug
Study focus
Drug/Device/Intervention
pembrolizumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Imperial College London
Funder
Health Technology Assessment Programme
Location
United Kingdom
Timeline & enrollment
Phase
Phase 3
Start date
Jan 14, 2022
End date
May 31, 2027
Enrollment
1750 participants
Summary

To determine the optimal dose frequency of pembrolizumab amongst patients with NSCLC who have benefited from and completed 6 months of standard therapy. To determine the longest frequency of pembrolizumab treatment that has similar effectiveness in terms of the following when compared to standard 6 weekly pembrolizumab in NSCLC patients who have completed and benefitted from 6 months of standard treatment: • Overall survival (OS); • Progression free survival (PFS), or the length of time that a participant is alive and the cancer has not come back or grown significantly; • Overall response rate (ORR), or the proportion of participants for whom the cancer either disappears or shrinks significantly; • Duration of response (DoR), or, in the proportion of patients for whom the cancer either disappears or shrinks significantly, the length of time between the disappearance or shrinking significantly and the shrinking stopping or the cancer coming back or growing significantly; • Safety and tolerability, or the side effects that are related to pembrolizumab; • Quality of life (QoL); • Cost effectiveness.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ISRCTN Registry
Trial ID
ISRCTN70247820
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for ISRCTN70247820 through Pure Global AI's free database. This Phase 3 trial is sponsored by Imperial College London and is currently status unknown. The study focuses on Non-small cell lung cancer. Target enrollment is 1750 participants.

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