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

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT06656598
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stage III NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (neoadjuvant chemotherapy only)
    Patients will receive neoadjuvant chemotherapy alone with carboplatin AUC 5 D1 and paclitaxel 80mg/m² D1 D8 D15 (3 cycles of 4 weeks). Patients will subsequently receive curative hypofractionated radiotherapy (55 Gy/20fr). After radiotherapy, patients will receive maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks for a period of 12 months.
  • Experimental: Arm B (neoadjuvant chemo-immunotherapy)
    Patients will receive neoadjuvant chemotherapy alone with carboplatin AUC 5 D1 and paclitaxel 80mg/m² D1 D8 D15 and cemiplimab 350 mg D1-D21 (3 cycles of 4 weeks). Patients will subsequently receive curative hypofractionated radiotherapy (55 Gy/20fr). After radiotherapy, patients will receive maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks for a period of 12 months.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: About 18 months ]

Central Contacts