RecruitingPhase 2NCT06656598

Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer

A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer


Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Enrollment

152 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding cemiplimab (an immunotherapy drug) to chemotherapy, followed by targeted radiation therapy, improves outcomes for older or frail patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for the standard more intensive treatment approach. **You may be eligible if...** - You are 18 or older with confirmed stage III NSCLC that cannot be surgically removed - If you are 70 or older, you have ECOG performance status 0–1 (reasonably active) - If you are under 70, you have ECOG 0–1 but are considered unfit for standard concurrent chemoradiation due to age-related or health factors - Your organ function meets required lab values **You may NOT be eligible if...** - Your lung cancer is stage I, II, or IV - You are fit enough to receive standard concurrent chemoradiation - You have active autoimmune disease or are on immune-suppressing medications - You have uncontrolled brain metastases 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCarboplatin

Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).

DRUGPaclitaxel

Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).

DRUGCemiplimab

Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).

RADIATIONCurative hypofractionated radiotherapy

Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.

DRUGCemiplimab (maintenance)

Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).


Locations(25)

Angers - Centre Paul Papin

Angers, France

Angers - CHU

Angers, France

Avignon - CH

Avignon, France

Boulogne - Ambroise Paré

Boulogne, France

Brest - CHU

Brest, France

Caen - CHU

Caen, France

Caen - CRLCC

Caen, France

Créteil - CHI

Créteil, France

Dijon - CRLCC

Dijon, France

Le Mans - CHG

Le Mans, France

Lille - CRLCC

Lille, France

Marseille - APHM

Marseille, France

Mulhouse - GHRMSA

Mulhouse, France

Paris - Bichat

Paris, France

Paris - Hôpital Cochin

Paris, France

Paris - Tenon

Paris, France

Bordeaux - CHU

Pessac, France

Lyon - HCL

Pierre-Bénite, France

Rennes - CHU

Rennes, France

Rouen - Centre Henri Becquerel

Rouen, France

Nantes - CRLCC

Saint-Herblain, France

Strasbourg - CRLCC

Strasbourg, France

Toulouse - CHU

Toulouse, France

Tours - CHU

Tours, France

Vandoeuvre-lès-Nancy - CRLCC

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06656598


Related Trials