Adaptive Treatment, Minimal Residual Disease, Non-small Cell Lung Cancer
Conditions
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.
Interventions
OTHERAdaptive postoperative management based on minimal residual disease
participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.
Sponsors
Peking University
Guangdong Provincial People's Hospital
Jiangsu Cancer Institute & Hospital
Shanghai Chest Hospital
Shandong Cancer Hospital and Institute
Shenzhen Third People's Hospital
Second Xiangya Hospital of Central South University
Shanghai Zhongshan Hospital
Peking University First Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
National Institute for Occupational Safety and Health (NIOSH/CDC)
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-year recurrence-free survival rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
| Incremental cost effectiveness ratio | 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. |
| Timely diagnosis rate by the novel MRD monitoring technique | 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. |
| Sensitivity of the novel MRD monitoring approach | 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. |
Countries
China
Contacts
Primary ContactKezhong Chen, MD
Backup ContactXiaoqiu Yuan
Outcome results
None listed