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NCT Number: NCT05965557

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between HRD and MPR rate/2 years DFS

    Time frame: 2023/12-2025/12

    Correlation between homologous recombination deficiency (HRD) events and major pathological response (MPR) rate and DFS of 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Shun Lu, PhD

CONTACT

[email protected]

+86 18017321551

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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