Radiotherapy Combined With ICIs as Treatment for LA-NSCLC After Failing Induction Immunochemotherapy (NCT06031597) | Clinical Trial Compass
UnknownPhase 3
Radiotherapy Combined With ICIs as Treatment for LA-NSCLC After Failing Induction Immunochemotherapy
105 participantsStarted 2023-09-15
Plain-language summary
Patients with stage III non-small-cell lung cancer initially evaluated as unresectable are selected for the program, who are remained unresectable after 2-4 cycles of conversion chemotherapy combined with immune checkpoint inhibitors. Investigators will stratify the treatment according to different performance status scores and radiotherapy plan bi-lung receptor volume to evaluate the safety and efficacy of immunotherapy followed by combined radiotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed non-small cell lung cancer
✓. Presence of at least one measurable lesion according to RECIST 1.1 criteria
✓. Classified as American Joint Committee on Cancer staging system, eighth edition (AJCC-8) Stage III, initially evaluated as unresectable and reevaluated as unresectable after 2-4 cycles of induction chemotherapy combined with immunotherapy
✓. Age 18-75
✓. Eastern Cooperative Oncology Group (ECOG) physical state score of 0-2
✓. Patients with the pathologic type of adenocarcinoma should be negative for driver genes (EGFR, anaplastic lymphoma kinase, ROS1)
✕. Radiotherapy plan for normal lung tissue V20 \> 30%, or average lung dose MLD \> 17 Gy
✕. Active or previous autoimmune disease (within the past 2 years) or history of primary immunodeficiency
✕. Patients with any other previous or current malignancy, except non-melanoma skin or cervical cancer in situ
✕. Any other disease or condition suggesting a contraindication to radiotherapy (e.g., active infection, within 6 months of myocardial infarction, symptomatic cardiac disease including unstable angina pectoris, congestive heart failure, or uncontrolled arrhythmias, immunosuppressive therapy)