non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed as stage IB–IIIB (AJCC 8th edition) non-small cell lung cancer (NSCLC), with histological subtypes of squamous cell carcinoma, adenocarcinoma, or large cell carcinoma; 2.Plan to receive standard neoadjuvant immunotherapy regimen (e.g., pembrolizumab combined with platinum-based doublet chemotherapy for 2–4 cycles) followed by surgical resection; 3.ECOG performance status 0–1 (normal daily activities, with mild limitation in strenuous physical activity); 4.Liver and kidney function, complete blood count, and other laboratory parameters meet the indications for immunotherapy (without severe organ dysfunction); 5.Voluntarily sign the informed consent form, and cooperate with sample collection and follow-up; 6.Age 18-75 years old, gender unlimited;
Exclusion criteria
Exclusion criteria: 1.Prior history of other malignancies (except for curative tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.); 2.Presence of severe cardiopulmonary disease (e.g., severe COPD, acute myocardial infarction within 3 months) or active pulmonary infection (e.g., pneumonia, tuberculosis); 3.Use of high-dose glucocorticoids (>=10 mg/day prednisone equivalent) or immunomodulators within the past 4 weeks; 4.Pregnant or lactating women; 5.Presence of oral diseases (e.g., severe gingivitis, oral ulcers) or recent (within 1 week) smoking or alcohol consumption (which may interfere with the VOCs profile); 6.Unable to cooperate with exhaled breath sample collection (e.g., severe cognitive impairment, dyspnea that prevents maintaining calm breathing);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Volatile Organic Compounds (VOCs) in Exhaled Breath Condensate;Pathologic Complete Response;Objective Response Rate; Event-Free Survival; | — |
Countries
China
Contacts
Peking University People's Hospital