Clinical trial · Observational
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
NCT03059641CI-TRIAL-00043139completedClinicalTrials.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 concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of informed consent * Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking 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 * 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 (1)
- DERIVEDAi X, Cui J, Zhang J, Chen R, Lin W, Xie C, Liu A, Zhang J, Yang W, Hu X, Hu X, Zhao Q, Rao C, Zang YS, Ning R, Li P, Chang L, Yi X, Lu S. Clonal Architecture of EGFR Mutation Predicts the Efficacy of EGFR-Tyrosine Kinase Inhibitors in Advanced NSCLC: A Prospective Multicenter Study (NCT03059641). Clin Cancer Res. 2021 Feb 1;27(3):704-712. doi: 10.1158/1078-0432.CCR-20-3063. Epub 2020 Nov 13. PMID 33188140