NSCLCMRDinS3LCNCT06081777
Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer
An observational study of NSCLC, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to 1 Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80. 2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities. 3. No driving gene EGFR/ALK mutation. 4. PS = 0-1.
Who may be able to join
- Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
- patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
- No driving gene EGFR/ALK mutation.
- PS = 0-1.
- the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.
Who cannot join
- patients suffering from other malignant tumors.
- patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
- Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
- Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.
Trial locations and contacts
1 site in 1 country.
Han Yin contact
About this study
Official title: A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer
Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.
Read the detailed description
In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.
- Conditions
- NSCLC
- Keywords
- MRD, potentially resectable NSCLC, stage III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arms1：For stage III NSCLC patients who underwent complete resection. | Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery (if any), adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis | |
| Arms 2：For stage III NSCLC patients who underwent concurrent radio-chemotherapy. | Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery, adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (RECIST)
Disease-free survival (RECIST)： the survival time from operation or radiation to recurrence
Measured: follow-up time: 2 years
Secondary outcomes (5)
OS
overall survival from the enrollment to death
Measured: follow-up for 2 years
The prediction of recurrence by positive MRD
Whether the prediction of recurrence by positive MRD is earlier than that confirmed by clinical diagnosis.
Measured: follow-up for 2 years
pCR rate of MRD-negative patient
pCR rate of MRD-negative patient
Measured: 2 years
Negative MRD rate in pCR patients
Negative MRD rate in pCR patients
Measured: follow-up time: 2 years
2-year DFS of ctDNA-negative patients in operation group / inoperable group
2-year DFS of ctDNA-negative patients in operation group / inoperable group
Measured: follow-up time: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start25 Nov 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 65 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Yuyan Wang, doctorate, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081777
- Sponsor's protocol ID
- LGH2022144
- Acronym
- MRDinS3LC
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06081777
- Acronym / sponsor ID
- MRDinS3LC / LGH2022144
- Conditions
- NSCLC
- Keywords
- MRD, potentially resectable NSCLC, stage III
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Geneplus-Beijing Co. Ltd.
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.
Detailed description
In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arms1：For stage III NSCLC patients who underwent complete resection. | – | –Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery (if any), adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis |
| Arms 2：For stage III NSCLC patients who underwent concurrent radio-chemotherapy. | – | –Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery, adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80. 2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities. 3. No driving gene EGFR/ALK mutation. 4. PS = 0-1.
Key inclusion criteria (5 listed)
- Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
- patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
- No driving gene EGFR/ALK mutation.
- PS = 0-1.
- the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.
Key exclusion criteria (4 listed)
- patients suffering from other malignant tumors.
- patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
- Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
- Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival (RECIST)
Time frame: follow-up time: 2 years
Disease-free survival (RECIST)： the survival time from operation or radiation to recurrence
5 secondary outcomes
OS
Time frame: follow-up for 2 years
The prediction of recurrence by positive MRD
Time frame: follow-up for 2 years
pCR rate of MRD-negative patient
Time frame: 2 years
Negative MRD rate in pCR patients
Time frame: follow-up time: 2 years
2-year DFS of ctDNA-negative patients in operation group / inoperable group
Time frame: follow-up time: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Han Yin contact
Yuyan Wang, doctorate principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Peking University Cancer Hospital & Institute 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 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuyan Wang (010-88196497, wangyuyan1219@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (RECIST) (time frame: follow-up time: 2 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 13 Oct 2023.