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

NCT ID: NCT05965557

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
Stage II-IIIB NSCLC who are undergoing neoadjuvant immunotherapy and surgical resection

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Shun Lu

Phone: +86 18017321551
Email: shunlu@sjtu.edu.cn

Start date: June 19, 2023

Completion date: December 2025

Lead sponsor:
Agency: Geneplus-Beijing Co. Ltd.
Agency class: Industry

Source: Geneplus-Beijing Co. Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05965557

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