SPLFIO-174
Research type
Research Study
Full title
A Phase 1b/2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression
IRAS ID
1009678
Contact name
Sue Russell
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (I.R.I.S.)
Clinicaltrials.gov Identifier
Research summary
The aim of the study is to test the safety, tolerability, and efficacy of 3 new immunotherapy investigational medications in combination with cemiplimab in people with non-small cell lung cancer (NSCLC).
The 3 new immunotherapy investigational medications are S095018, S095024, and S095029 (together, these will be called “S-compounds”). They have been tested in patients with advanced solid tumours alone, or in combination with an immunotherapy similar to cemiplimab. In this study, the S-compounds will be tested in combination with cemiplimab.
This study is divided into 2 parts, Part A and Part B. Participants will be assigned to Part A or Part B depending on the progress of the study.
Part A: The main aim of Part A is to determine the safety of each treatment combination, how well each combination therapy is tolerated, and to confirm the recommended doses for testing in a larger number of patients with the same lung cancer (in Part B).
Part B: The main aim of Part B is to determine the efficacy of each treatment combination and which treatment combination is most effective in treating this lung cancer compared to cemiplimab alone.
Each immunotherapy treatment will be administered intravenously over 30 minutes (with a delay of at least 30 minutes between each infusion) every 3 weeks on Day 1 of each 21-day cycle. The maximum duration of the treatment period will be approximately 2 years.
Participants will be followed up at end of treatment every 12 weeks until participant’s death, withdrawal of consent, lost to follow-up or sponsor’s decision to terminate the study.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0244
Date of REC Opinion
25 Sep 2024
REC opinion
Further Information Favourable Opinion