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

Geneplus Technology (Gene+)

Status

Enrolling

Conditions

Lung Neoplasms

Lung Cancer, Nonsmall Cell

Squamous Cell Lung Cancer

Adenocarcinoma of Lung

Treatments

Other: Observation

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04566432

TRACELib002

Details and patient eligibility

About

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.

Full description

In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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