Clinical trial · Observational
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
NCT04566432CI-TRIAL-00116223completedClinicalTrials.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)
To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Immune checkpoint inhibitors
- interventionNames
- Other: Observation
- label
- Targeted therapy
- description
- Targeting ALK, ROS1, MET ex14 skipping
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- the evolution of ctDNA mutation profile during treatment
- timeFrame
- every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)
- description
- ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of informed consent * Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively * No EGFR mutation in tissue and ctDNA * Received immune checkpoint inhibitors as the first line therapy * ECOG performance status 0-2 with expected more than 6 months of survival time * Willingness to comply with required protocols and give permission to use the data for clinical research and products development Exclusion Criteria: * Patients have other primary cancers * Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders * Patients failed in either plasma or tissue sample QC
References
Publications (0)
Data not yet available
No reference posted for this study.