Status:
UNKNOWN
Radiotherapy Combined With ICIs as Treatment for LA-NSCLC After Failing Induction Immunochemotherapy
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Non-small Cell Lung Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a prospective, real-world cohort study, which aimed to evaluate the safety and efficacy of immunotherapy followed by combined radiotherapy. Participants will be selected and entered into three...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06031597
Start Date
September 15 2023
End Date
December 31 2025
Last Update
September 13 2023
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