Actively Recruiting
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
Led by Fang Wu · Updated on 2025-04-23
100
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
F
Fang Wu
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)
CONDITIONS
Official Title
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥ 18 years old
- Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
- General condition: ECOG score 0 or 1
- First-line monotherapy or combination immunotherapy
- The long-term benefit of immunotherapy was defined as PFS=12months
- Tumor tissue samples can be obtained at the time of enrollment, and at least 5 ~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
- At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
- Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
- Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.
You will not qualify if you...
- Serious primary diseases of the heart, liver and kidney
- Other malignant tumors within 3 years prior to diagnosis of NSCLC
- Women in pregnancy and lactation
- The active stage of human immunodeficiency virus (HIV) infection
- Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
- Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oncology Department，Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
C
Chunhong Hu, professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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