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

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

NCT ID: NCT06241807

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

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Camrelizumab
Non-Small Cell Lung Cancer
Neoadjuvant Therapy
Biomarkers Analysis

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab Plus Chemotherapy
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])
Arm group label: Camrelizumab Plus Chemotherapy Arm

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shandong Cancer Hospital and Institute

Address:
City: Jinan
Zip: 250117
Country: China

Status: Recruiting

Contact:
Last name: Xue Meng, MD, PhD

Phone: +86-17653115602
Email: mengxue5409@163.com

Contact backup:
Last name: Guoxin Cai, MD

Phone: +33-751440039
Email: Guoxin.CAI@gustaveroussy.fr

Start date: December 2, 2022

Completion date: December 31, 2026

Lead sponsor:
Agency: Shandong Cancer Hospital and Institute
Agency class: Other

Source: Shandong Cancer Hospital and Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06241807