NCT05198154 ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
| NCT ID | NCT05198154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fang Wu |
| Condition | Advanced Lung Non-Small Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-01-24 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05198154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Lung Non-Small Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05198154 currently recruiting?
Yes, NCT05198154 is actively recruiting participants. Contact the research team at huchunh5829@126.com for enrollment information.
Where is the NCT05198154 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05198154 clinical trial?
NCT05198154 is sponsored by Fang Wu. The trial plans to enroll 100 participants.