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NCT Number: NCT06930807

Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are:

* How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer? * Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival? * Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?

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Key information

Conditions

Non-small Cell Lung Cancer Adaptive Treatment Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Kezhong Chen, MD

CONTACT

[email protected]

+86-010-88325983

About this study

Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.

This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
  • Solid nodules >1 cm or ground-glass nodules >1.5 cm on imaging
  • No history of malignancies other than non-small cell lung cancer in the past 5 years
  • Specimens are well preserved and imaging documents are accessible.

Exclusion criteria

  • Age<18 years old
  • Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
  • Pathology results confirmed not to be non-small cell lung cancer
  • History of malignancies other than non-small cell lung cancer in the past 5 years

Treatment and study plan

Adaptive postoperative management based on minimal residual disease

Other

participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.

Primary outcomes

  1. Two-year recurrence-free survival rate

    Time frame: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.

    The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years.

Secondary outcomes

  1. Overall survival

    Time frame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.

    The difference in overall survival between the intervention group and the control group.

  2. Incremental cost effectiveness ratio

    Time frame: 24 months after surgery

    The cost of lung cancer-related treatment, including the cost of drugs, follow-up treatment, drug management costs (consultation fees, anti-tumor drug allocation fees, intravenous infusion fees, nursing fees, etc.), follow-up costs, laboratory tests and imaging examination costs, and the management costs of adverse reactions (1 cycle is counted as 1 time), and the per capita standard expenses calculated according to the Checkmate816 study protocol and China's expenses were used to calculate ICER.

  3. Timely diagnosis rate by the novel MRD monitoring technique

    Time frame: two years

    The proportion of patients with recurrence signals detected by non-invasive methods prior to clinical confirmation of recurrence/metastasis, and quantify the mean lead time.

  4. Sensitivity of the novel MRD monitoring approach

    Time frame: two years

    Evaluate the sensitivity of the novel MRD-based assay against previous ctDNA-MRD-only approaches. Use receiver operating characteristic (ROC) curves and limit of detection (LoD) analyses for cross-platform comparison.

Study contacts

Contact information is provided by the study sponsor or research team.

Kezhong Chen, MD

CONTACT

[email protected]

+86-010-88325983

Xiaoqiu Yuan

CONTACT

[email protected]

+86-010-88325983

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Guangdong Provincial People's Hospital
  • Jiangsu Cancer Institute & Hospital
  • National Institute for Occupational Safety and Health (NIOSH/CDC)
  • Peking University
  • Peking University First Hospital
  • Second Xiangya Hospital of Central South University
  • Shandong Cancer Hospital and Institute
  • Shanghai Chest Hospital
  • Shanghai Zhongshan Hospital
  • Shenzhen Third People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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