NCT06656598

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage III NSCLC

Interventions

Type	Name	Description
DRUG	Carboplatin	Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
DRUG	Paclitaxel	Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
DRUG	Cemiplimab	Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).
RADIATION	Curative hypofractionated radiotherapy	Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.
DRUG	Cemiplimab (maintenance)	Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).

Timeline

• Start date: 2025-11-07
• Primary completion: 2028-09-01
• Completion: 2032-01-01
• First posted: 2024-10-24
• Last updated: 2026-02-11

Locations

25 sites across 1 country: France