Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Jan 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combination of a new immunotherapy drug called camrelizumab with chemotherapy to treat patients with resectable stage IIIA and IIIB non-small cell lung cancer (NSCLC). The goal is to see how effective this treatment is and to ensure it is safe for patients before they undergo surgery to remove the cancer. To participate in the trial, patients need to be between 18 and 75 years old, have a confirmed diagnosis of stage IIIA or IIIB NSCLC that can be surgically removed, and must not have certain genetic mutations related to lung cancer.

Participants in the trial will receive three cycles of camrelizumab along with standard chemotherapy before their surgery, which will take place about 4 to 6 weeks after finishing chemotherapy. Throughout the study, patients will have scans and blood tests to monitor their progress and gather information on how well the treatment is working. It's important to note that this trial is currently recruiting, and patients who have other active cancers, certain health conditions, or who are pregnant or breastfeeding cannot participate.

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ALL

Eligibility criteria

• 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