Brief Title
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
Official Title
Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
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 Type
Observational
Primary Outcome
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
Secondary Outcome
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
Condition
Lung Neoplasms
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
300
Start Date
February 22, 2017
Completion Date
January 30, 2020
Primary Completion Date
December 31, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Shun Lu, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03059641
Organization ID
TRACELib-NSCLC
Responsible Party
Sponsor
Study Sponsor
Geneplus-Beijing Co. Ltd.
Collaborators
Shanghai Chest Hospital
Study Sponsor
Shun Lu, MD, Principal Investigator, Shanghai Chest Hospital
Verification Date
February 2020