Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Geneplus-Beijing Co. Ltd.300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Lung Neoplasms Lung Cancer, Nonsmall Cell Adenocarcinoma of Lung Squamous Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

First Hospital of Jilin University

Changchun, China

Sir Run Run Shaw Hospital, Zhejiang University School of medicine

Hangzhou, China

Outcomes

Primary Outcomes

The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.

Time frame: 2 years

Secondary Outcomes

The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.

Time frame: 1 year

Data from ClinicalTrials.gov

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