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

NCT06241807 | Recruiting Phase 2

• 1 other identifier: SDZL-MX-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Camrelizumab; Non-Small Cell Lung Cancer; Neoadjuvant Therapy; Biomarkers Analysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse events

  24 weeks

• Disease-free survival

  24 months

Other Outcomes (1)

• Molecular imaging research and biomarker analysis

  20 weeks

Study Arms (1)

Camrelizumab Plus Chemotherapy Arm

EXPERIMENTAL

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

Interventions

Camrelizumab Plus Chemotherapy DRUG

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

Camrelizumab Plus Chemotherapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

Related Publications (1)

• Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10.

  PMID: 40348946 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xue Meng, MD, PhD

CONTACT

+86-17653115602; mengxue5409@163.com

Guoxin Cai, MD

CONTACT

+33-751440039; Guoxin.CAI@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: December 2, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

CN (1)