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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05965557

Enrollment

100

Registered

2023-07-28

Start date

2023-06-19

Completion date

2027-12-01

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

CONTACTShun Lu, PhD

shunlu@sjtu.edu.cn+86 18017321551

Outcome results