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Exhaled Breath Testing: A Non-Invasive Method for Predicting the Efficacy of Immunotherapy in Lung Cancer

New Method for Non-invasive Efficacy Prediction of Neoadjuvant Immunotherapy in Lung Cancer: Development and Clinical Application Validation of Exhaled Breath Detection Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121628
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

Cohort of Resectable Stage IB-?B NSCLC Patients Planned to Receive Neoadjuvant Immunotherapy:None

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Major pathological remission;

Secondary

MeasureTime frame
Volatile Organic Compounds (VOCs) in Exhaled Breath Condensate;Pathologic Complete Response;Objective Response Rate; Event-Free Survival;

Countries

China

Contacts

Public ContactMantang Qiu

Peking University People's Hospital

qiumantang@163.com+86 10 88325983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026