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

Shandong First Medical University

Status and phase: Enrolling; Phase 2

Conditions: Resectable Lung Non-Small Cell Carcinoma; Neoadjuvant Therapy; IMMUNOTHERAPY; Biomarkers / Blood

Treatments: Drug: Camrelizumab Plus Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06241807

SDZL-MX-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Camrelizumab Plus Chemotherapy Arm

Experimental group

Description:

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 \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])

Treatment:

Drug: Camrelizumab Plus Chemotherapy