Clinical trial · Observational
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
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)
NCT05198154CI-TRIAL-00124798CR1STALactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group)
- description
- The ctDNA detection will be performed using a tumor-informed analysis approach. This method requires the availability of tumor tissue samples or a fixed-panel next-generation sequencing (NGS) test.
- interventionNames
- Diagnostic Test: ctDNA detection
- label
- Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group)
- description
- The ctDNA detection will be performed using a tumor-agnostic analysis. This method does not require tumor tissue samples or an NGS testing panel, or in cases where tissue samples are available but fail to meet quality control standards.
- interventionNames
- Diagnostic Test: ctDNA detection
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.