RecruitingNCT05965557

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

A Biomarker Study for Predicting the Response of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Based on Circulating Tumor DNA and Homologous Recombination Deficiency Analysis


Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

100 participants

Start Date

Jun 19, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria2

  • A history of other malignancies within the past 5 years
  • Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy

Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT05965557


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