Monitoring ctDNA to assess progression risk in advanced lung cancer after immunotherapy
A Multicenter, Prospective Clinical Study of Circulating Tumor DNA Analysis to Monitor the Risk of Progression After Long-term Benefit to First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)
This study is testing if measuring tumor DNA in the blood can help predict when advanced lung cancer might get worse in patients who have benefited from immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05198154 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between circulating tumor DNA (ctDNA) levels and the risk of disease progression in patients with advanced non-small cell lung carcinoma (NSCLC) who have experienced long-term benefits from first-line immunotherapy. Participants will have their plasma collected every three months for ctDNA analysis using high-depth panel sequencing until disease progression occurs. The study aims to determine the predictive value of ctDNA for progression risk and to identify the lead time of detectable ctDNA prior to conventional imaging findings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced NSCLC who have had a progression-free survival of at least 12 months following first-line immunotherapy.
Not a fit: Patients with driver gene mutations (EGFR/ALK/ROS1) or those who have not benefited from first-line immunotherapy may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a noninvasive method to monitor disease progression in advanced lung cancer patients, potentially leading to timely interventions.
How similar studies have performed: Previous studies have shown promise in using ctDNA analysis for monitoring cancer progression, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- Oncology Department，Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Chunhong Hu, professor
- Email: huchunh5829@126.com
- Phone: +86 13508486908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.