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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntergroupe Francophone de Cancerologie Thoracique

About this trial

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 criteria

Qualifiers

Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.

Age ≥ 18 years.

Histologically or cytologically confirmed locally advanced non small cell lung cancer (NSCLC) stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015.

Disqualifiers

Immunotherapy or chemotherapy contra-indicated.

Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.

Stage I or II NSCLC.

Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.

Trial design

Treatments tested in this trial

  • Carboplatin
  • Paclitaxel
  • Cemiplimab
  • Curative hypofractionated radiotherapy
  • Cemiplimab (maintenance)

Treatment groups

152 Participants
are divided into 2 treatment groups