Lung NeoplasmsNCT07894458
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
A study testing Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response in people with Lung Neoplasms and Neoadjuvant Therapy, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Neoplasms, Neoadjuvant Therapy, Immunotherapy
- What is being tested?
- Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2026to 31 Oct 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female, aged ≥ 18 and < 85 years.
- Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
- Tumor tissue and blood samples obtainable at all protocol-specified time-points.
- No pure ground-glass nodule on imaging.
- Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.
Who cannot join
- Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
- Insufficient or poor-quality blood or tissue samples.
- Pure ground-glass nodule on imaging.
- History of any malignancy within the past 5 years.
- Contraindication to surgery preventing radical resection.
- Non-radical (R2) resection.
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- Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
- Refusal or withdrawal of informed consent.
- Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).
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
Yue He, +86-010-88325983, hy771999@163.com
About this study
Official title: Establishment of Post-Operative Optimal Surveillance Model and Adaptive Treatment Decision System Based on MRD Molecular Response Combined With Pathological Response Status
This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based minimal residual disease (MRD) testing and pathological response-can effectively improve the 2-year postoperative recurrence-free survival (RFS). The study will enroll 100 patients scheduled for radical surgery who have undergone neoadjuvant immunotherapy (in combination with platinum-based chemotherapy). Patients will receive individualized follow-up and adjuvant therapy based on dynamic changes in ctDNA at various preoperative and postoperative timepoints, as well as pathological response. Adjuvant therapy will be recommended if patients do not achieve pathological complete response (pCR) after surgery, or if ctDNA testing is positive after neoadjuvant therapy or post-surgery. Only patients who achieve pCR and have negative ctDNA at both specified timepoints will forgo adjuvant therapy; these patients will undergo blood sampling at each routine follow-up, with adjuvant therapy initiated upon ctDNA seroconversion to positive. The primary endpoint is 2-year RFS after surgery; secondary endpoints include overall survival (OS) and the diagnostic rate of recurrence/metastasis based on ctDNA-MRD testing. This project aims to explore the refinement of adaptive treatment strategies in the neoadjuvant immunotherapy lung cancer population, with the ultimate goal of improving overall therapeutic efficacy and establishing a standardized, integrated postoperative management system suitable for lung cancer patients.
- Being tested
- Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response
- Keywords
- NSCLC, Perioperative monitoring, Postoperative surveillance, Liquid biopsy, MRD, Minimal residual disease
- Medical subject headings
- Lung Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive therapy of de-escalation and escalation based on MRD testing and pathological responseOther
Postoperative adjuvant therapy is administered if any of the following criteria are met: absence of pathological complete response (pCR), positive preoperative ctDNA after neoadjuvant therapy, or positive postoperative ctDNA. Treatment regimens are determined by multidisciplinary review. Monthly blood sampling is performed during adjuvant therapy. Based on current evidence, treatment de-escalation based solely on ctDNA status is not supported in lung cancer patients receiving neoadjuvant immunotherapy. Thus, patients achieving pCR with negative ctDNA at both predefined timepoints receive no adjuvant therapy. Blood is collected at routine follow-up visits, and adjuvant therapy is initiated upon ctDNA seroconversion to positive.
| Study group | Role | What they receive |
|---|---|---|
| MRD-Guided Adaptive Postoperative Management Group | Experimental | Not described Receives: Other: Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year recurrence-free survival rate
Measured: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.
Secondary outcomes (2)
Overall survival
Measured: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start12 Aug 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen KeZhong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894458
- Sponsor's protocol ID
- BRWEP2024W034080204-2
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Post-Operative Optimal Surveillance Model and Adaptive Treatment Decision System Based on MRD Molecular Response Combined With Pathological Response Status
- ClinicalTrials.gov ID
- NCT07894458
- Acronym / sponsor ID
- BRWEP2024W034080204-2
- Keywords
- NSCLC, Perioperative monitoring, Postoperative surveillance, Liquid biopsy, MRD, Minimal residual disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
This study is a prospective single-arm clinical trial targeting patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who have received neoadjuvant immunotherapy. The primary objective is to evaluate whether a personalized follow-up and adjuvant treatment strategy-based on the combination of ctDNA-based minimal residual disease (MRD) testing and pathological response-can effectively improve the 2-year postoperative recurrence-free survival (RFS). The study will enroll 100 patients scheduled for radical surgery who have undergone neoadjuvant immunotherapy (in combination with platinum-based chemotherapy). Patients will receive individualized follow-up and adjuvant therapy based on dynamic changes in ctDNA at various preoperative and postoperative timepoints, as well as pathological response. Adjuvant therapy will be recommended if patients do not achieve pathological complete response (pCR) after surgery, or if ctDNA testing is positive after neoadjuvant therapy or post-surgery. Only patients who achieve pCR and have negative ctDNA at both specified timepoints will forgo adjuvant therapy; these patients will undergo blood sampling at each routine follow-up, with adjuvant therapy initiated upon ctDNA seroconversion to positive. The primary endpoint is 2-year RFS after surgery; secondary endpoints include overall survival (OS) and the diagnostic rate of recurrence/metastasis based on ctDNA-MRD testing. This project aims to explore the refinement of adaptive treatment strategies in the neoadjuvant immunotherapy lung cancer population, with the ultimate goal of improving overall therapeutic efficacy and establishing a standardized, integrated postoperative management system suitable for lung cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD-Guided Adaptive Postoperative Management Group | Experimental | Other: Adaptive therapy of de-escalation and escalation based on MRD testing and pathological response |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent.
- Male or female, aged ≥ 18 and < 85 years.
- Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
- Tumor tissue and blood samples obtainable at all protocol-specified time-points.
- No pure ground-glass nodule on imaging.
Key exclusion criteria (9 listed)
- Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
- Insufficient or poor-quality blood or tissue samples.
- Pure ground-glass nodule on imaging.
- History of any malignancy within the past 5 years.
- Contraindication to surgery preventing radical resection.
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 therapy of de-escalation and escalation based on MRD testing and pathological responsePostoperative adjuvant therapy is administered if any of the following criteria are met: absence of pathological complete response (pCR), positive preoperative ctDNA after neoadjuvant therapy, or positive postoperative ctDNA. Treatment regimens are determined by multidisciplinary review. Monthly blood sampling is performed during adjuvant therapy. Based on current evidence, treatment de-escalation based solely on ctDNA status is not supported in lung cancer patients receiving neoadjuvant immunotherapy. Thus, patients achieving pCR with negative ctDNA at both predefined timepoints receive no adjuvant therapy. Blood is collected at routine follow-up visits, and adjuvant therapy is initiated upon ctDNA seroconversion to positive. | Other | MRD-Guided 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.
2 secondary outcomes
Overall survival
Time frame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.
Timely diagnosis rate by the novel MRD monitoring technique
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 26 Oct 2026.
- 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.
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 therapy of de-escalation and escalation based on MRD testing and pathological response in people with Lung Neoplasms and Neoadjuvant Therapy, 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 6 inclusion and 9 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 26 Oct 2026. 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 (+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 26 Oct 2026.