Clinical trial NCT06524518: 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
Official title: Xuanwu Hospital Capital Medical University
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: DFS
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

1. Age: 18-80 years old
2. gender: men and women can be balanced as far as possible
3. Patients with clinically confirmed stage II-III NSCLC by histopathology have operable conditions
4. 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
5. ECOG behavior status score 0 \~ 1
6. EGFR or ALK driver gene mutation negative
7. 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

Exclusion Criteria:

1. Any other anti-tumor treatment before surgery
2. Patients with previous history of other malignant tumors
3. Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence
4. CT scan at baseline revealed idiopathic pulmonary fibrosis. 4. Pregnant or lactating women
5. multiple lung cancer patients
6. 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:

1. 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
2. Liver: serum bilirubin \> 1.5 times the upper limit of normal
3. Serum creatinine \> 1.25 times the normal value
4. 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

Primary outcomes:
measure: DFS
timeFrame: MRD-positive patients were treated 3 years after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Eijing
Study officials:
affiliation: Capital Medical University
name: Yi Zhang, MD,PhD
role: STUDY_CHAIR
References: