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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059641
• Other study ID #: TRACELib-NSCLC
• Status: Completed
• Start date: February 22, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: Geneplus-Beijing Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms
• Squamous Cell Lung Cancer

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of medicine	Hangzhou
China	The First Hospital of Zhejiang Province	Hangzhou
China	Anhui Provincial Hospital	Hefei
China	Jiangsu Jiangyin People's Hospital	Jiangyin
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	Ningbo No.2 Hospital	Ningbo
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Changzheng Hospital	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Shanghai East Hospital	Shanghai
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Affiliated Hospital, Jiangnan University	Wuxi

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.		2 years
Secondary	The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.		1 year