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

IMMUNOTHERAPY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241807
• Other study ID #: SDZL-MX-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Shandong Cancer Hospital and Institute
• Contact: Xue Meng, MD, PhD
• Phone: +86-17653115602
• Email: mengxue5409[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?109/L, Thrombocytes = 100 ? 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 ? 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• IMMUNOTHERAPY
• Neoadjuvant Therapy
• Resectable Lung Non-Small Cell Carcinoma

Intervention

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])

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	Adverse events	Number and percentage of cases of all adverse events	24 weeks
Secondary	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