ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC

Launched by FANG WU · Jan 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a test called circulating tumor DNA (ctDNA) to help monitor patients with advanced lung cancer, specifically non-small cell lung carcinoma (NSCLC). The goal is to see if ctDNA can predict the risk of the cancer getting worse in patients who have benefited from their first treatment with immunotherapy for at least 12 months. Immunotherapy is a type of treatment that helps the body's immune system fight cancer.

To be eligible for this trial, participants need to be between 18 and 75 years old, have advanced non-small cell lung cancer that does not have certain genetic markers (like EGFR, ALK, or ROS1), and must have shown a good response to their initial immunotherapy. They should also be in relatively good health overall and able to understand and agree to participate in the study. If you join this trial, you can expect to provide some tumor samples and undergo regular monitoring to track your health and the effectiveness of the treatment. This research may help doctors better understand how to use ctDNA in managing lung cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
• • General condition: ECOG score 0 or 1
• • First-line monotherapy or combination immunotherapy
• • The long-term benefit of immunotherapy was defined as PFS=12months
• • Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
• • At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
• • Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
• • Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.
• Exclusion Criteria:
• • Serious primary diseases of the heart, liver and kidney
• • Other malignant tumors within 3 years prior to diagnosis of NSCLC
• • Women in pregnancy and lactation
• • The active stage of human immunodeficiency virus (HIV) infection
• • Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
• • Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.