NCT05965557Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Jul 2023
- Start date
- 19 Jun 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Geneplus-Beijing Co. Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT05965557
What you commit to
- Study type: Observational
- Planned participants: 100
- From 19 Jun 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of other malignancies within the past 5 years
- Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
Who the study is looking for
- Stage II-IIIB NSCLC
- EGFR/ALK negative
- The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.