Clinical trial NCT06930807: Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer
Official title: Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Minimal Residual Disease
Adaptive Treatment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Guangdong Provincial People's Hospital
name: Jiangsu Cancer Institute & Hospital
name: Shanghai Chest Hospital
name: Shandong Cancer Hospital and Institute
name: Shenzhen Third People's Hospital
name: Second Xiangya Hospital of Central South University
name: Shanghai Zhongshan Hospital
name: Peking University First Hospital
name: Wuhan Union Hospital, China
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2025-04-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Two-year recurrence-free survival rate
timeFrame: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.
Secondary outcomes:
measure: Overall survival
timeFrame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
measure: Incremental cost effectiveness ratio
timeFrame: 24 months after surgery
measure: Timely diagnosis rate by the novel MRD monitoring technique
timeFrame: two years
measure: Sensitivity of the novel MRD monitoring approach
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Kezhong Chen, MD
role: STUDY_CHAIR
affiliation: Peking University
name: Guangxi Wang, PhD
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Jiatao Zhang, MD
role: STUDY_DIRECTOR
affiliation: Jiangsu Cancer Institute & Hospital
name: Rong Yin, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Chest Hospital
name: Ziming Li, MD
role: STUDY_DIRECTOR
affiliation: Shandong Cancer Hospital and Institute
name: Yintao Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Third People's Hospital
name: Zizi Zhou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Xiangya Hospital of Central South University
name: Fang Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Jun Yin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Yuan Cheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Quanfu Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: China National Institute for Occupational Safety and Health (NIOSH/CDC)
name: Xiaojun Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
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