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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241807
Other study ID # SDZL-MX-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 2, 2022
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source Shandong Cancer Hospital and Institute
Contact Xue Meng, MD, PhD
Phone +86-17653115602
Email mengxue5409@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ?109/L, Thrombocytes = 100 ? 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 ? 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Camrelizumab Plus Chemotherapy
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])

Locations

Country Name City State
China Shandong Cancer Hospital and Institute Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Molecular imaging research and biomarker analysis Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment 20 weeks
Primary Major Pathological Response Rate No more than 10% of tumor cells were found in neoadjuvant surgical specimens From date of surgery to 14 days later
Primary Pathologic complete response rate No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes From date of surgery to 14 days later
Secondary Adverse events Number and percentage of cases of all adverse events 24 weeks
Secondary Disease-free survival The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason 24 months
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