NCT06524518Not yet recruitingPhase 2
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
Xuanwu Hospital Capital Medical University
Source: ClinicalTrials.gov · Last updated 6 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 213 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- Aug 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Lung cancer
- NCT number
- NCT06524518
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 213
- From Aug 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other anti-tumor treatment before surgery
- Patient's organ system status:
- 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:
Other illness
- 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
- multiple lung cancer patients
Lab values
- 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
Other
- CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.