Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Exploring biomarkers for neoadjuvant immunotherapy in lung cancer

Official 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

Run by Geneplus-Beijing Co. Ltd. · NCT05965557 · Data updated 2026-11-12

This study is trying to find out if certain biological markers in patients with advanced lung cancer can help predict how well a new immunotherapy treatment will work before surgery.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment100 (estimated)
SponsorGeneplus-Beijing Co. Ltd.
Industry-sponsored
Drugs / interventionsimmunotherapy
Locations1 site (Shanghai)
StatusRecruiting
StartedJune 19, 2023
Main results expectedJune 2027
Study endsDecember 2027
Registry record updatedJune 30, 2026
Trial IDNCT05965557 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with stage II-IIIB non-small cell lung cancer who are EGFR and ALK negative.

Probably not a fit

Patients with a history of other malignancies within the past 5 years or those with autoimmune diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify predictive biomarkers for the efficacy of neoadjuvant immunotherapy in patients with non-small cell lung cancer (NSCLC) who are stage II-IIIB and driver-negative. It will prospectively collect data from patients scheduled for neoadjuvant immunotherapy and surgical resection, focusing on homologous recombination deficiency (HRD) as a potential biomarker. Additionally, blood samples will be analyzed for circulating tumor DNA (ctDNA) to assess its correlation with treatment efficacy and patient prognosis. The goal is to validate the predictive value of these biomarkers in a larger cohort.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with lung cancer.

How similar studies have gone: While the approach of using HRD and ctDNA as predictive markers is promising, it requires validation in larger cohorts, indicating that this area is still under exploration.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Shanghai Chest Hospital
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.