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

Capital Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

DFS

Treatments

Drug: Chemotherapy combined with immunization

Study type

Interventional

Funder types

Other

Identifiers

NCT06524518

XuanwuH-NSCLC-MINT

Details and patient eligibility

About

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).

Enrollment

213 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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

Sign informed consent

Exclusion criteria

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:

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

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.
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].
Situations considered unsuitable for inclusion by other researchers