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

Launched by GENEPLUS-BEIJING CO. LTD. · Sep 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well a blood test called ctDNA (circulating tumor DNA) can predict how lung cancer patients respond to treatments known as immune checkpoint inhibitors. These are therapies designed to help the body’s immune system fight cancer. The trial is specifically looking at patients with advanced lung cancer, either adenocarcinoma or squamous cell carcinoma, who have recently started these treatments. Researchers want to see if ctDNA can help identify which patients are likely to respond well or have a relapse.

To participate in this trial, patients must be between 65 to 74 years old and have a confirmed diagnosis of stage IIIB-IV lung cancer that hasn’t shown certain genetic mutations. They should also be receiving immune checkpoint inhibitors as their first treatment and have a good performance status, meaning they are able to take care of themselves most of the time. Patients with other active cancers or serious brain complications won't be eligible. Those who join the trial can expect to provide blood samples for testing and will help researchers learn more about how to improve treatment for lung cancer patients in the future.

Gender

ALL

Eligibility criteria

• 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