Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

Korábbi kezelés

• History of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.
• History of prior systemic therapy (immunotherapy, chemotherapy, or targeted therapy) for lung cancer.

Más betegség

• Known severe allergic reactions to PD-1 or PD-L1 inhibitors (Grade ≥3 by CTCAE).
• Active autoimmune disease requiring systemic immunosuppression.
• Active infections, including active HBV, HCV, or HIV infection.
• Any comorbid condition or uncontrolled illness that, in the opinion of the investigator, may interfere with study participation or pose unacceptable risk.

Laborértékek

• Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK/ROS1 rearrangements.

Egyéb

• Participants meeting any of the following criteria will be excluded:
• Presence of uncontrolled or symptomatic brain metastases.
• Pregnant or breastfeeding women.

• Participants must meet all of the following criteria:
• Age ≥18 and ≤75 years at the time of enrollment.
• Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC).
• Deemed suitable for neoadjuvant immunotherapy combined with platinum-based chemotherapy and subsequent surgical resection based on multidisciplinary team (MDT) assessment.
• ECOG Performance Status of 0 or 1.
• No prior systemic antitumor therapy for the current NSCLC diagnosis.
• Adequate bone marrow, hepatic, renal, and cardiac function based on local laboratory standards.
• Willing and able to comply with scheduled visits, treatment plans, and other study procedures.
• Signed informed consent prior to participation.