RecruitingNCT04566432

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy

Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

250 participants

Start Date

Jul 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Summary

To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Provision of informed consent
Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or 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
No EGFR mutation in tissue and ctDNA
Received immune checkpoint inhibitors as the first line therapy
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 Criteria3

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