Tests blood and tumor markers that may predict response to lung cancer immunotherapy
Studies blood DNA and tumor repair markers in lung cancer patients receiving immunotherapy before surgery.
Key facts
- Who runs it
- Geneplus-Beijing Co. Ltd.
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 19 Jun 2023
- Expected to end
- Dec 2027
- Type of study
- Observational
- Record updated
- 30 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage II-IIIB non-small cell lung cancer, without EGFR or ALK changes, who will have immunotherapy before surgery.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Stage II-IIIB non-small cell lung cancer (NSCLC)
- Biomarker or test result
- EGFR/ALK negative
Main reasons for not taking part
- Another cancer within the past 5 years
- Autoimmune disease
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Stage II-IIIB NSCLC
- EGFR/ALK negative
- The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up
Who cannot take part
- A history of other malignancies within the past 5 years
- Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Shanghai Chest HospitalShanghai, ChinaContact: Shun LuTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests blood and tumor markers that may predict response to lung cancer immunotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05965557, who can take part
- Record updated
- 30 June 2026