Non Small Cell Lung CancerNCT06443684
A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
An observational study of Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 14 sites in China.
Trial summary
The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- MRD
- How many people
- 305 participants
- Where
- 14 sitesChina
- Study dates
- 8 May 2023to 31 Dec 2027
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected
Who may be able to join
- Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
- Age≥ 18
- ECOG PS:0-1
- Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\ALK\ROS1\RET\KRAS\PIK3CA\BRAF\HER2\MET
- Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
- Provide 20 mL peripheral blood samples periodically
- The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up
Who cannot join
- Patients with other malignancies within 5 years
- According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
- The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Hunan Cancer Hospital
Changsha, Hunan
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang
The First Affiliated Hospital of USTC / Anhui Provincial Hospital
Hefei, Anhui, 230000
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Shandong Provincial Hospital
Jinan, Shandong
Shanghai Chest hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Shanxi Cancer Hospital
Taiyuan, Shanxi
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi
First Affiliated Hospital of Xiamen University
Xiamen, Fujian
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:
- Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance
Read the detailed description
Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.
The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- MRD
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRDDiagnostic test
MRD（LC-10）include 10 lung cancer-related driver gene mutation site
| Study group | Role | What they receive |
|---|---|---|
| Direct surgery | Stage III NSCLC eligible for direct surgery
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site Receives: Diagnostic Test: MRD | |
| Neoadjuvant and surgery | Stage III NSCLC eligible for neoadjuvant therapy followed by surgery
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site Receives: Diagnostic Test: MRD | |
| Chemoradiotherapy | Unresectable Stage III NSCLC eligible for Chemoradiotherapy.
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site Receives: Diagnostic Test: MRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events
Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
Measured: 2022.12--2025.03
Secondary outcomes (3)
Correlation of MRD status in driver gene-positive NSCLC patients with RFS
Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
Measured: 2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with OS
Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery.
Measured: 2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events
Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
Measured: 2022.12--2025.03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start8 May 2023
- Primary completion7 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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 Shanghai Chest 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Shun, Shanghai Chest Hospital
- Investigators
- Shun Lu, M.D., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443684
- Sponsor's protocol ID
- ADX-MRD-LC
- Status last verified
- Jun 2026
- First submitted
- 30 May 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
- ClinicalTrials.gov ID
- NCT06443684
- Acronym / sponsor ID
- ADX-MRD-LC
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (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 prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:
- Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance
Detailed description
Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.
The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct surgery | – | Diagnostic Test: MRDStage III NSCLC eligible for direct surgery Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site |
| Neoadjuvant and surgery | – | Diagnostic Test: MRDStage III NSCLC eligible for neoadjuvant therapy followed by surgery Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site |
| Chemoradiotherapy | – | Diagnostic Test: MRDUnresectable Stage III NSCLC eligible for Chemoradiotherapy. Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected
Key inclusion criteria (7 listed)
- Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
- Age≥ 18
- ECOG PS:0-1
- Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\ALK\ROS1\RET\KRAS\PIK3CA\BRAF\HER2\MET
- Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
Key exclusion criteria (3 listed)
- Patients with other malignancies within 5 years
- According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
- The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
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 |
|---|---|---|
| MRDMRD（LC-10）include 10 lung cancer-related driver gene mutation site | Diagnostic test | Chemoradiotherapy, Direct surgery, Neoadjuvant and surgery |
Primary outcome
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events
Time frame: 2022.12--2025.03
Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
3 secondary outcomes
Correlation of MRD status in driver gene-positive NSCLC patients with RFS
Time frame: 2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with OS
Time frame: 2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events
Time frame: 2022.12--2025.03
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 17 Jun 2026.
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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. This study is not recruiting at the moment.
Shun Lu, M.D. principal investigator
Shanghai Chest Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Shanghai Chest Hospital at 14 sites 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events (time frame: 2022.12--2025.03). 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 17 Jun 2026.