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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuanwu Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.