ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
Recruiting now
Conditions studied: Advanced Lung Non-Small Cell Carcinoma
In brief
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)
Key facts
- Study ID
- NCT05198154
- Run by
- Fang Wu
- People needed
- 100
- Starts
- 2022-01-24
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2025-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- Oncology Department，Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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