Back to resultsRadiotherapy Combined With ICIs as Treatment for LA-NSCLC After Failing Induction Immunochemotherapy
Non-small Cell Lung Cancer Stage III
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Stage III focused on measuring Non-small cell lung cancer, Immune checkpoint inhibitors, Radiotherapy, Radiation pneumonitis
Eligibility Criteria
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) Serum hemoglobin ≥ 90 g/L, platelets ≥ 90 × 109/L, absolute neutrophil count ≥ 1.2 × 109/L Serum creatinine ≤ 1.25 times upper limit of normal(ULN) or creatinine clearance ≥ 60 mL/min Serum bilirubin ≤ 1.5 times ULN, (AST) and alanine aminotransferase aspartate aminotransferase (ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN Forced expiratory volume in one second (FEV1)>0.8 liter Normal coagulation function (Prothrombin time prolonged by no more than 3s and activated partial thromboplastin time prolonged by no more than 10s) Patients signed a formal informed consent form to indicate that they understood that the study complied with the hospital's policies and ethical requirements Exclusion Criteria: The pathologic type is lung carcinoid or small cell lung cancer Patients with any distant metastases Grade 2 or higher unresolved toxic effects after conversion therapy (according to the Common Terminology Criteria for Adverse Events CTCAE) A recent efficacy rating of PD after conversion therapy 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) Pregnant or nursing women Women and men who are at risk of becoming pregnant but are unwilling to use adequate contraception Evidence of hereditary bleeding disorders or coagulation disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort A: concurrent chemoradiotherapy combined with ICIs
Cohort B: concurrent radiotherapy combined with ICIs
Cohort C: radiotherapy
For performance status (PS)=0-1 and both lungs V20≤20%, mean lung dose (MLD)≤11 gray(Gy), then the patient should be treated with concurrent chemo-radiotherapy and immunotherapy, and immunotherapy should be given after chemo-radiotherapy to maintain up to 1 year. Participants eligible for enrollment will receive radiotherapy within 8 weeks of the end of chemotherapy combined with Immune checkpoint inhibitors (ICIs) at a radical prescribed dose of 60 Gy ± 10% at 2 Gy once daily for 5 days per week. The chemotherapy regimen will be cisplatin at a dose of 25 mg/m2 once a week for 5-6 cycles. Marketed programmed cell death 1 (PD-1) or programmed cell death L1 (PD-L1) inhibitors are chosen as immunotherapy agents. Immunotherapy will be given every 3 weeks, with no more than 3 cycles of immunotherapy during radiotherapy. The dosage is recommended according to the drug insert.
For PS=0-1 and 20%<both lungs V20≤25% or 11Gy<MLD≤13Gy, radiotherapy alone combined with concurrent immunotherapy, followed by immunotherapy up to 1 year. Participants eligible for enrollment will receive radiotherapy within 8 weeks of the end of chemotherapy combined with ICIs at a radical prescribed dose of 60 Gy ± 10% at 2 Gy once daily for 5 days per week. Marketed PD-1 or PD-L1 inhibitors are chosen as immunotherapy agents. Immunotherapy will be given every 3 weeks, with no more than 3 cycles of immunotherapy during radiotherapy. The dosage is recommended according to the drug insert.
For PS=2 or 25%<both lungs V20≤30% or 13Gy<MLD≤17Gy, radiotherapy alone, followed by immunotherapy for up to 1 year. Participants eligible for enrollment will receive radiotherapy within 8 weeks of the end of chemotherapy combined with ICIs at a radical prescribed dose of 60 Gy ± 10% at 2 Gy once daily for 5 days per week. Marketed PD-1 or PD-L1 inhibitors are chosen as immunotherapy agents. The dosage is recommended according to the drug insert.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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