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NCT Number: NCT06443684

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

The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:

1) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of USTC / Anhui Provincial Hospital, Hefei, Anhui, China

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About this study

Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.

The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
  • Age≥ 18
  • ECOG PS:0-1
  • 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
  • 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
  • Provide 20 mL peripheral blood samples periodically
  • 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

  • Patients with other malignancies within 5 years
  • According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
  • 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

Treatment and study plan

MRD

Diagnostic Test

MRD(LC-10)include 10 lung cancer-related driver gene mutation site

Primary outcomes

  1. Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events

    Time frame: 2022.12--2025.03

    Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.

Secondary outcomes

  1. Correlation of MRD status in driver gene-positive NSCLC patients with RFS

    Time frame: 2022.12--2025.03

    Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.

  2. Correlation of MRD status in driver gene-positive NSCLC patients with OS

    Time frame: 2022.12--2025.03

    Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery.

  3. Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events

    Time frame: 2022.12--2025.03

    Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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