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Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-02-23

No results posted yet for this study

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

DRUG

Cemiplimab

Cemiplimab is provided in a 10 ml glass vial

DRUG

Placebo

standard saline solution

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Dirk de Ruysscher, MD · Maastro Clinic - Maastricht Radiation Oncology, Maastricht, Netherlands

  • Frank Aboubakar Nana, MD · Cliniques Universitaires Saint-Luc, Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-14
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219317 on ClinicalTrials.gov