Non-small Cell Lung CancerNCT06930807
Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer
A study testing Adaptive postoperative management based on minimal residual disease in people with Non-small Cell Lung Cancer and Minimal Residual Disease, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Minimal Residual Disease, Adaptive Treatment
- What is being tested?
- Adaptive postoperative management based on minimal residual disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Kezhong Chen, MD, +86-010-88325983, mdkzchen@163.com
About this study
Official title: Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in 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?
Read the 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.
- Being tested
- Adaptive postoperative management based on minimal residual disease
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive postoperative management based on minimal residual diseaseOther
participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.
| Study group | Role | What they receive |
|---|---|---|
| adaptive postoperative management group | Experimental | For those who don't receive neoadjuvant therapy, if the MRD testing results after surgery keep negative, postoperative adjuvant therapy will be waived.
For those who receive neoadjuvant therapy, if the efficacy reaches pathological complete response(pCR) and MRD testing results keep negative, postoperative adjuvant therapy will be waived.
Otherwise, participants will receive a customized treatment plan based on Multi-disciplinary Treatment (MDT). Receives: Other: Adaptive postoperative management based on minimal residual disease |
| standard clinical postoperative management group | No intervention | These participants will receive standard postoperative adjuvant therapy and routine follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year recurrence-free survival rate
The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years.
Measured: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.
Secondary outcomes (4)
Overall survival
The difference in overall survival between the intervention group and the control group.
Measured: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
Incremental cost effectiveness ratio
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.
Measured: 24 months after surgery
Timely diagnosis rate by the novel MRD monitoring technique
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.
Measured: two years
Sensitivity of the novel MRD monitoring approach
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start25 Mar 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Principal investigator, Chen KeZhong, Peking University People's Hospital
- Investigators
- Kezhong Chen, MD, Study chair, Peking University People's HospitalGuangxi Wang, PhD, Study director, Peking UniversityJiatao Zhang, MD, Study director, Guangdong Provincial People's HospitalRong Yin, MD, Study director, Jiangsu Cancer Institute & HospitalZiming Li, MD, Study director, Shanghai Chest HospitalYintao Li, MD, Principal investigator, Shandong Cancer Hospital and InstituteZizi Zhou, MD, Principal investigator, Shenzhen Third People's HospitalFang Wu, MD, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930807
- Sponsor's protocol ID
- 2023ZD0501900
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer
- ClinicalTrials.gov ID
- NCT06930807
- Acronym / sponsor ID
- 2023ZD0501900
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adaptive postoperative management group | Experimental | Other: Adaptive postoperative management based on minimal residual diseaseFor those who don't receive neoadjuvant therapy, if the MRD testing results after surgery keep negative, postoperative adjuvant therapy will be waived. For those who receive neoadjuvant therapy, if the efficacy reaches pathological complete response(pCR) and MRD testing results keep negative, postoperative adjuvant therapy will be waived. Otherwise, participants will receive a customized treatment plan based on Multi-disciplinary Treatment (MDT). |
| standard clinical postoperative management group | No intervention | –These participants will receive standard postoperative adjuvant therapy and routine follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive postoperative management based on minimal residual diseaseparticipants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative. | Other | adaptive postoperative management group |
Primary outcome
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.
4 secondary outcomes
Overall survival
Time frame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
Incremental cost effectiveness ratio
Time frame: 24 months after surgery
Timely diagnosis rate by the novel MRD monitoring technique
Time frame: two years
Sensitivity of the novel MRD monitoring approach
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kezhong Chen, MD study chair
Peking University People's Hospital
Guangxi Wang, PhD study director
Peking University
Jiatao Zhang, MD study director
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive postoperative management based on minimal residual disease in people with Non-small Cell Lung Cancer and Minimal Residual Disease, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kezhong Chen, MD (+86-010-88325983, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year recurrence-free survival rate (time frame: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.