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

NCT06656598 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-02-11

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Intergroupe Francophone de Cancerologie Thoracique

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2028-09-30
Completion
2032-01-31

Countries

  • France

Study Locations

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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 NCT06656598 on ClinicalTrials.gov