Neoadjuvant Camrelizumab Combined With Chemotherapy for Rese...

About this study

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.

Condition: IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma, Biomarkers / Blood
Tested: Camrelizumab Plus Chemotherapy
Sponsor: Shandong Cancer Hospital and Institute

Who can join

Age: 18 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 9

Minimum age: 18 years
Maximum age: 75 years
Study condition: IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma, Biomarkers / Blood
Age 18-75
Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
Absence of EGFR, ALK, and ROS1 gene mutations
Eastern Cooperative Oncology Group (ECOG) status 0-1
Signed written informed consent prior to the implementation of any trial-related rocedures
Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \> 5 x ULN, Bilirubin \> 1.5 х ULN

Exclusion 10

Patients diagnosed with any other malignant tumor
Have received prior therapy with chemotherapy or immune checkpoint inhibitor
Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
A history of interstitial lung disease or non-infectious pneumonia
Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
Patients who have received allogeneic stem cell or solid organ transplantation
Women during pregnancy or lactation

Where

1 site, 1 recruiting

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Recruiting

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