A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC

Plain-language summary

This study examines monitoring of molecular residual disease (MRD) and its relationship with recurrence in patients with stage III non-small cell lung cancer (NSCLC) carrying a driver gene mutation. It is enrolling patients aged 18 and older, confirmed by imaging and tissue biopsy, whose tumor is positive for a driver gene such as EGFR, ALK, ROS1, RET, KRAS, BRAF, HER2 or MET. It is being run as a study with no assigned phase; it is not currently recruiting but is ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Shanghai Chest Hospital

Intervention

MRD

Start date

5/8/2023

Estimated completion

12/31/2027

Countries

China

Related genes

Locations

• Hefei, China
• Xiamen, China
• Guangzhou, China
• Harbin, China
• Zhengzhou, China
• Changsha, China
• Jinan, China
• Jinan, China
• Shanghai, China
• Shanghai, China
• Taiyuan, China
• Xi’an, China
• Hangzhou, China
• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
2. Age≥ 18
3. ECOG PS:0-1
4. Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\\ALK\\ROS1\\RET\\KRAS\\PIK3CA\\BRAF\\HER2\\MET
5. Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
6. Provide 20 mL peripheral blood samples periodically
7. The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up

Exclusion Criteria:

1. Patients with other malignancies within 5 years
2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
3. The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples