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

A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Neoadjuvant Therapy; Resectable Lung Non-Small Cell Carcinoma; IMMUNOTHERAPY; Biomarkers / Blood
• Intervention / Treatment: Drug: Camrelizumab Plus Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xue Meng, MD, PhD; Phone Number: +86-17653115602; Email: mengxue5409@163.com
• Study Contact Backup: Name: Guoxin Cai, MD; Phone Number: +33-751440039; Email: Guoxin.CAI@gustaveroussy.fr

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital and Institute
      • Contact: Xue Meng, MD, PhD; Phone Number: +86-17653115602; Email: mengxue5409@163.com
      • Contact: Guoxin Cai, MD; Phone Number: +33-751440039; Email: Guoxin.CAI@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab Plus Chemotherapy Arm; 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])	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])

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number and percentage of cases of all adverse events	24 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Neoadjuvant Therapy; Camrelizumab; Biomarkers Analysis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SDZL-MX-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No