Spots Global Cancer Trial Database for Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
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Trial Identification
Brief Title: Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Official Title: Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Study ID: NCT06219317
Conditions
Study Description
Brief Summary: This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Dirk de Ruysscher, MD
Affiliation: Maastro Clinic - Maastricht Radiation Oncology, Maastricht, Netherlands
Role: STUDY_CHAIR
Name: Frank Aboubakar Nana, MD
Affiliation: Cliniques Universitaires Saint-Luc, Brussels, Belgium
Role: STUDY_CHAIR
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