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Trial Title:
Exploration of Predictive Markers of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
NCT ID:
NCT05965557
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Stage II-IIIB NSCLC who are undergoing neoadjuvant immunotherapy and surgical resection
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu
Phone:
+86 18017321551
Email:
shunlu@sjtu.edu.cn
Start date:
June 19, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Geneplus-Beijing Co. Ltd.
Agency class:
Industry
Source:
Geneplus-Beijing Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965557