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

NCT06241807 · tracked via the Priya Life Science China tracker

Sponsor

Shandong Cancer Hospital and Institute

Phase

Phase 2

Started

2022-12-02

Last updated

2024-02-14

Condition(s) studied

IMMUNOTHERAPYNeoadjuvant TherapyResectable Lung Non-Small Cell CarcinomaBiomarkers / Blood

Investigational drug(s) / intervention(s)

Camrelizumab Plus Chemotherapy →

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Shandong Cancer Hospital and Institute	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06241807 on ClinicalTrials.gov ↗ ← All trials in China