NCT06219317

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab is provided in a 10 ml glass vial
DRUG	Placebo	standard saline solution

Timeline

• Start date: 2025-01-14
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-01-23
• Last updated: 2026-02-23

Locations

16 sites across 5 countries: Belgium, France, Italy, Netherlands, Spain