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

Sponsor

Geneplus-Beijing Co. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03059641

Collaborator

Shanghai Chest Hospital (Other)

300

Enrollment

Locations

35.2

Actual Duration (Months)

21.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Lung Cancer, Nonsmall Cell Adenocarcinoma of Lung Squamous Cell Lung Cancer

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China

Actual Study Start Date :

Feb 22, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jan 30, 2020

Outcome Measures

Primary Outcome Measures

The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment. [2 years]

Secondary Outcome Measures

The concordance of gene mutation pattern between liquid biopsy and tissue biopsy. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
2	First Hospital of Jilin University	Changchun		China
3	Sir Run Run Shaw Hospital, Zhejiang University School of medicine	Hangzhou		China
4	The First Hospital of Zhejiang Province	Hangzhou		China
5	Anhui Provincial Hospital	Hefei		China
6	Jiangsu Jiangyin People's Hospital	Jiangyin		China
7	The Second Affiliated Hospital of Nanchang University	Nanchang		China
8	Ningbo No.2 Hospital	Ningbo		China
9	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai		China
10	Shanghai Changzheng Hospital	Shanghai		China
11	Shanghai Chest Hospital	Shanghai		China
12	Shanghai East Hospital	Shanghai		China
13	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou		China
14	Affiliated Hospital, Jiangnan University	Wuxi		China