A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.

Launched by NATIONAL CANCER CENTER, JAPAN · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how to better manage treatment for patients with early to mid-stage non-small cell lung cancer (NSCLC), which is a common type of lung cancer. The researchers want to find out how well a new test, called ctDNA-based minimal residual disease (MRD) analysis, can help identify which patients might benefit from additional therapies after their initial treatment, such as surgery or chemotherapy. By using this test, they hope to reduce unnecessary treatments for patients who are likely to do well without them, making the treatment process easier and less costly.

To be part of this study, participants must be at least 18 years old and have a confirmed diagnosis of NSCLC that is either stage I, II, or III and suitable for curative treatment. This means their cancer can potentially be completely removed or treated. Patients will need to provide tissue and blood samples for the study. The trial is currently not recruiting participants, so it will begin in the future. Those who join can expect to help improve understanding of how to personalize lung cancer treatment, which could lead to better outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
• • The diagnosis (by cytology or biopsy) must be one of the following: "adenocarcinoma," "squamous cell carcinoma," "non-small cell carcinoma consistent with adenocarcinoma," "non-small cell carcinoma consistent with squamous cell carcinoma," or "non-small cell carcinoma not otherwise specified (NOS)." If the histological subtype differs between cytology and biopsy specimens, the subtype determined by the biopsy specimen shall be used.
• • At the time of enrollment, diagnoses of "squamous cell carcinoma" or "non-small cell carcinoma consistent with squamous cell carcinoma" are classified as squamous cell carcinoma, whereas "adenocarcinoma," "non-small cell carcinoma consistent with adenocarcinoma," and "non-small cell carcinoma NOS" are classified as non-squamous cell carcinoma.
• 2. Meets one of the following criteria (1-3):
• • 1. Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.
• • 2. Stage III disease deemed amenable to curative-intent chemoradiotherapy. 3. Stage II-III (preoperative clinical stage) deemed resectable, with planned neoadjuvant therapy.
• • 3) Age ≥ 18 years at the time of enrollment. 4) The attending physician has determined that tissue and blood samples can be provided.
• • 5) Written informed consent has been obtained from the patient.
• Exclusion Criteria:
• • Presence of active multiple primary malignancies (defined as synchronous multiple cancers/tumors or metachronous multiple cancers/tumors with a disease-free interval of 3 years or less). However, even if the disease-free interval is less than 3 years, a history of clinical stage I prostate cancer or a completely resected cancer with any of the pathological stages specified below is not considered "active multiple primary malignancies.