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Recruiting Phase 2 NCT06718309

Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

Trial Parameters

Condition Non-Small Cell Lung Cancer
Sponsor First People's Hospital of Hangzhou
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-24
Completion 2027-04-30
Interventions
ChemotherapyImmunotherapyRadical resection of lung cancer

Brief Summary

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.

Eligibility Criteria

Inclusion Criteria: 1. Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients; 2. Age ≥18 years; 3. (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1; 4. According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor \> 7cm); 5. Puncture or biopsy samples were tested EGFR/ALK negative; 6. Surgically or potentially resectable after discussion by multidisciplinary team (MDT); 7. Who has not received systemic antitumor therapy and has not received chest radiotherapy; 8. Evaluable lesions in the lung or mediastinum; 9. The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥100\*10\^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total

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