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
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.
• 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.
• Patients over 70 years of age with Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS of 0 to 1.
• Or Patients under 70 years of age with ECOG PS of 0 to 1 and a score ≥ 3 according to the Charlson comorbidity criterion or ECOG PS 2.
• Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.
• Measurable disease according to RECIST 1.1.
• Respiratory function:
‣ FEV1 ≥ 40% of theoretical value,
⁃ DLCO ≥ 40%.
• Bone marrow function:
‣ absolute neutrophil count (ANC) ≥ 1.5.109/L,
⁃ platelets ≥ 100.109/L,
⁃ hemoglobin ≥ 9 g/dl.
⁃ Renal and hepatic function:
∙ estimated creatinine clearance ≥ 45 ml/min,
‣ bilirubin ≤1.5xULN,
‣ AST ALT ≤3xULN,
‣ Albumin ≥28g/dl.
⁃ Participant has national health insurance coverage.
⁃ Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential.