DFSPhase 2NCT06524518
A Multicenter Randomized Controlled Study of Interventional Treatment for Operable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer With Potential Recurrence as Minimal Residual Disease(MRD) Positive
A Phase 2 study testing Chemotherapy combined with immunization in people with DFS, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DFS
- What is being tested?
- Chemotherapy combined with immunization
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Dec 2029
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old
- gender: men and women can be balanced as far as possible
- Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
- no previous exposure to immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 And anti-PD-L2 antibodies
- ECOG behavior status score 0 ~ 1
- EGFR or ALK driver gene mutation negative
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- organ function level meets the conditions: 1) Hematological examination indicators: absolute neutrophil count (ANC) ≥1.8×109/L, platelet count ≥ 100×109/L, hemoglobin ≥9 g/dL.
- 2) Appropriate liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN), aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤2.5×ULN 3) Appropriate renal function: serum creatinine ≤1.25×ULN, or creatinine clearance ≥60 mL/min
- 8. Sign informed consent
Who cannot join
- Any other anti-tumor treatment before surgery
- Patients with previous history of other malignant tumors
- Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
- CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
- multiple lung cancer patients
- Patient's organ system status:
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- 1) Prior interstitial lung disease, drug-induced interstitial disease, radiation pneumonia or REN requiring hormone therapy Any clinical evidence of active interstitial lung disease 2) In the investigator's judgment, there is a severe or uncontrollable systemic disease (e.g. unstable or uncompensable) Evidence of respiratory, heart, liver or kidney disease) 3) Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, Congestive heart failure, liver, kidney or metabolic disease) 4) Can not accept oral administration, need intravenous high energy nutrition, prior surgery affecting absorption or live Patients with dynamic peptic ulcer
- 7. Functional level of patients with various organ lesions:
- Bone marrow: absolute neutrophil count (ANC) < 1.5×109/L, platelets < 90×109/L or blood V1.1 2024.5.29 Albumin < 9 g/dl
- Liver: serum bilirubin > 1.5 times the upper limit of normal
- Serum creatinine > 1.25 times the normal value
- any other disease, neurological or metabolic disorder, the evidence of physical examination or laboratory test results is reasonable Suspected illness or presence of counterindications of use of related drugs or placing subjects at high levels of treatment-related complications The possibility of risk.
- 8. No R0 resection [ananatomical lobectomy/total pulmonary resection + systemic lymph node dissection (including at least 3 groups of N1) And 3 groups of N2 lymph nodes), both gross and microscopic incisal margins were negative].
- 9. Situations considered unsuitable for inclusion by other researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yi Zhang, MD,PhD contact
About this study
Official title: Xuanwu Hospital Capital Medical University
A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
- Conditions
- DFS
- Being tested
- Chemotherapy combined with immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy combined with immunizationDrug
MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy
| Study group | Role | What they receive |
|---|---|---|
| MRD-negative follow-up | Sham comparator | Not described Receives: Drug: Chemotherapy combined with immunization |
| MRD-positive follow-up | No intervention | Not described |
| MRD-positive adaptive therapy | Experimental | Not described Receives: Drug: Chemotherapy combined with immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
3 years
Measured: MRD-positive patients were treated 3 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DFSStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, MD,PhD, Study chair, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524518
- Sponsor's protocol ID
- XuanwuH-NSCLC-MINT
- Status last verified
- Jun 2024
- First submitted
- 23 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xuanwu Hospital Capital Medical University
- ClinicalTrials.gov ID
- NCT06524518
- Acronym / sponsor ID
- XuanwuH-NSCLC-MINT
- Conditions
- DFS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Jul 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.
A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRD-negative follow-up | Sham comparator | Drug: Chemotherapy combined with immunization |
| MRD-positive follow-up | No intervention | – |
| MRD-positive adaptive therapy | Experimental | Drug: Chemotherapy combined with immunization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-80 years old
- gender: men and women can be balanced as far as possible
- Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
- no previous exposure to immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 And anti-PD-L2 antibodies
- ECOG behavior status score 0 ~ 1
Key exclusion criteria (14 listed)
- Any other anti-tumor treatment before surgery
- Patients with previous history of other malignant tumors
- Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
- CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
- multiple lung cancer patients
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 |
|---|---|---|
| Chemotherapy combined with immunizationMRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy | Drug | MRD-negative follow-up, MRD-positive adaptive therapy |
Primary outcome
DFS
Time frame: MRD-positive patients were treated 3 years after intervention
3 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 6 Aug 2024.
- 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.
Yi Zhang, MD,PhD contact
Yi Zhang, MD,PhD study chair
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy combined with immunization in people with DFS, run by Xuanwu Hospital, Beijing 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 6 Aug 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoru Tian (18618330855, xiaoru9u@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: MRD-positive patients were treated 3 years after intervention). 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 6 Aug 2024.