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

NCT ID: NCT03059641

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-22

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role collaborator

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shun Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

First Hospital of Jilin University

Changchun, , China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of medicine

Hangzhou, , China

Site Status

The First Hospital of Zhejiang Province

Hangzhou, , China

Site Status

Anhui Provincial Hospital

Hefei, , China

Site Status

Jiangsu Jiangyin People's Hospital

Jiangyin, , China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Ningbo No.2 Hospital

Ningbo, , China

Site Status

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Shanghai Chest Hospital

Shanghai, , China

Site Status

Shanghai East Hospital

Shanghai, , China

Site Status

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Site Status

Affiliated Hospital, Jiangnan University

Wuxi, , China

Site Status

Countries

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China

References

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Ai 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.

Reference Type DERIVED
PMID: 33188140 (View on PubMed)

Other Identifiers

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TRACELib-NSCLC

Identifier Type: -

Identifier Source: org_study_id

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