Efficacy and Safety of NSCLC Patients With or Without Adjuvant Immunotherapy Who Have Achieved Pathologic Complete Remission After Neoadjuvant Immunotherapy: A Prospective Real-World Study

RWNEOADJ-01

This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.

2024-02-01

2027-09-01

2027-12-01

Recruiting

100

Inclusion Criteria: 1. Histologically or cytologically confirmed resectable/potentially resectable NSCLC of stage IB-IIIB (AJCC 8th edition). 2. Completed neoadjuvant immunotherapy (3 cycles) and achieved pathological complete response (pCR) postoperatively. 3. With or without adjuvant immunotherapy postoperatively. 4. Underwent at least one effective imaging evaluation during the adjuvant treatment period. Exclusion Criteria: 1. Incomplete clinical data for patients, such as missing treatment history, surgical specimen pathology results, etc. 2. Follow-up data less than 36 months. 3. Patients with multiple primary tumors. 4. History of malignancy other than NSCLC within the past 5 years. 5. Previous treatment with PD-1/PD-L1 inhibitors. 6. Excluded patients with positive EGFR/ALK driver gene mutations 7. Receipt of other investigational drugs during the observation period.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-02-06