Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer

NCT05965557 · tracked via the Priya Life Science China tracker

Sponsor

Geneplus-Beijing Co. Ltd.

Phase

Observational

Started

2023-06-19

Last updated

2026-06-30

Condition(s) studied

Lung Cancer

Study summary

Neoadjuvant immunotherapy has become the standard perioperative treatment in lung cancer, but its effective predictive biomarkers are lacking. A small cohort reported that homologous recombination deficiency (HRD) can be used as a reliable biomarker to predict the efficacy of neoadjuvant immunotherapy, but the findings need to be validated in larger cohorts. Moreover, circulating tumor DNA (ctDNA) has the potential to predict the therapeutic efficacy of neoadjuvant immunotherapy.

This study intends to prospectively collect patients with driver-negative stage II-IIIB NSCLC who are scheduled to receive neoadjuvant immunotherapy and surgical resection and verify the value of HRD in predicting the efficacy of neoadjuvant immunotherapy. Meanwhile, the blood samples before and after neoadjuvant immunotherapy were collected for high-depth ctDNA detection to explore the correlation between the dynamic changes of ctDNA and the efficacy and prognosis of neoadjuvant immunotherapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Stage II-IIIB NSCLC * EGFR/ALK negative * The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up Exclusion Criteria: * A history of other malignancies within the past 5 years * Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy

Primary outcome measure(s)

Correlation between HRD and MPR rate/2 years DFS — 2023/12-2025/12
Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years

Trial sites (1)

Facility	City	Region	Status
Shanghai Chest Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05965557 on ClinicalTrials.gov ↗ ← All trials in China