NCT06926179 Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer
| NCT ID | NCT06926179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | Lung Cancer (NSCLC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-03-31 |
Trial Parameters
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Brief Summary
This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations; 2. Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment; 3. Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy); 4. Assessed as resectable or potentially resectable by surgical experts prior to treatment. Exclusion Criteria: 1. Confirmed M1 disease; 2. History of previous lung malignancy or other metastatic malignant tumors; 3. Participation in other randomized controlled trials involving neoadjuvant treatment; 4. Significant missing clinical data.
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