Biomarkers / Blood, IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma
Conditions
Keywords
Camrelizumab, Non-Small Cell Lung Cancer, Neoadjuvant Therapy, Biomarkers Analysis
Brief summary
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.
Interventions
Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response Rate | From date of surgery to 14 days later | No more than 10% of tumor cells were found in neoadjuvant surgical specimens |
| Pathologic complete response rate | From date of surgery to 14 days later | No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 weeks | Number and percentage of cases of all adverse events |
| Disease-free survival | 24 months | The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason |
Other
| Measure | Time frame | Description |
|---|---|---|
| Molecular imaging research and biomarker analysis | 20 weeks | Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment |
Countries
China
Contacts
Primary ContactXue Meng, MD, PhD
Backup ContactGuoxin Cai, MD
Outcome results
None listed