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Completed

NCT Number: NCT03059641

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

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.

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Key information

Conditions

Lung Neoplasms Adenocarcinoma Adenocarcinoma of Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer, Nonsmall Cell Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Lung Cancer Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Collaborators

  • Shanghai Chest Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 23, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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