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

Completed

• Conditions: Lung Neoplasms; Lung Cancer, Nonsmall Cell; Adenocarcinoma of Lung; Squamous Cell Lung Cancer

• Registration Number: NCT03059641
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

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.

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 Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study Start: 2017-02-22
• Study First Posted: 2017-02-23
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.	2 years

Secondary Outcome Measures

Name	Time	Method
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.	1 year

Trial Locations

Locations (14)

First Hospital of Jilin University; 🇨🇳 Changchun, China

Anhui Provincial Hospital; 🇨🇳 Hefei, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, China

Sir Run Run Shaw Hospital, Zhejiang University School of medicine; 🇨🇳 Hangzhou, China

Ningbo No.2 Hospital; 🇨🇳 Ningbo, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China

Affiliated Hospital, Jiangnan University; 🇨🇳 Wuxi, China

Jiangsu Jiangyin People's Hospital; 🇨🇳 Jiangyin, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

The First Hospital of Zhejiang Province; 🇨🇳 Hangzhou, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China