RecruitingPhase 2NCT06219317

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC


Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

136 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether immunotherapy with cemiplimab (an immune checkpoint inhibitor) given after aggressive local treatments (surgery and/or radiation) can prevent cancer recurrence in patients with non-small cell lung cancer (NSCLC) that was limited to a small number of sites when first diagnosed (called oligometastatic disease). **You may be eligible if...** - You are 18 or older with confirmed NSCLC - At diagnosis, your cancer had spread to a maximum of 5 spots in no more than 3 organs (oligometastatic) - Your cancer remained oligometastatic at the time of study entry - You are in good overall health (ECOG/WHO 0–1) - Your blood counts and organ function are acceptable **You may NOT be eligible if...** - Your lung cancer has small-cell features - Your cancer has spread beyond the oligometastatic threshold - You are pregnant or breastfeeding - You have a history of severe autoimmune disease - You have active brain metastases not adequately treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

Cemiplimab is provided in a 10 ml glass vial

DRUGPlacebo

standard saline solution


Locations(16)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

CHU Helora Pole Hospitalier Jolimont

Haine-Saint-Paul, Belgium

CHU Mont Godinne - UCL Namur

Yvoir, Belgium

CH de La Cote Basque - Saint Leon

Bayonne, France

Institut Paoli-Calmettes

Marseille, France

Groupe Hospitalier Paris Saint Joseph

Paris, France

ASST Ovest Milanese - Legnano

Legnano, Italy

Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

Legnano, Italy

Fondazione IRCCS - Policlinico San Matteo

Pavia, Italy

AUSL Della Romagna - Ospedale Santa Maria delle Croci

Ravenna, Italy

Azienda Ospedaliero - Universitaria "Santa Maria della Misericordia" di Udine

Udine, Italy

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

UOMi Cancer Center

Barcelona, Spain

Hospital Quironsalud Sagrado Corazon

Seville, Spain

University Hospital Virgen del Rocio

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT06219317


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