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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05965557
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China