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
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.
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
February 22, 2017
January 30, 2020
Primary Completion Date
December 31, 2019
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
18 Years - 80 Years
Accepts Healthy Volunteers
Shun Lu, MD, ,
Geneplus-Beijing Co. Ltd.
Shanghai Chest Hospital
Shun Lu, MD, Principal Investigator, Shanghai Chest Hospital