Clinical trial NCT06241807: Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Official title: A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IMMUNOTHERAPY
Neoadjuvant Therapy
Resectable Lung Non-Small Cell Carcinoma
Biomarkers / Blood
Keywords: Camrelizumab
Non-Small Cell Lung Cancer
Neoadjuvant Therapy
Biomarkers Analysis
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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) \&gt; 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \&gt; 5 x ULN, Bilirubin \&gt; 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 outcomes:
measure: Major Pathological Response Rate
timeFrame: From date of surgery to 14 days later
measure: Pathologic complete response rate
timeFrame: From date of surgery to 14 days later
Secondary outcomes:
measure: Adverse events
timeFrame: 24 weeks
measure: Disease-free survival
timeFrame: 24 months
Other outcomes:
measure: Molecular imaging research and biomarker analysis
timeFrame: 20 weeks
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
References: