Phase 2 Study of Camrelizumab and Chemotherapy Before Surgery for Treating Stage IIIA-IIIB Resectable Non-Small Cell Lung Cancer
Led by Shandong Cancer Hospital and Institute · Updated on 2024-02-14
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in patients with resectable stage IIIA and IIIB non-small cell lung cancer NSCLC. This Phase II trial focuses on patients aged 18 to 75 with specific tumor stages and no EGFR, ALK, or ROS1 gene mutations. The goal is to assess the treatments ability to improve tumor response before surgery and to monitor safety and progression outcomes.
Participants receive three cycles of camrelizumab 200 mg combined with chemotherapy drugs including nab-paclitaxel or pemetrexed plus platinum-based agents such as cisplatin or carboplatin. After completing chemotherapy, patients undergo curative surgery within 4 to 6 weeks. Imaging with 18F-fluorodeoxyglucose FDG PETCT scans is performed one week before treatment starts and one week before surgery. Blood samples are collected to analyze biomarkers.
During the study, patients are monitored for major pathological response and complete pathological response within 14 days after surgery. Safety is assessed over 24 weeks, and disease-free survival is followed for up to 24 months. Researchers also explore molecular imaging and biomarker analysis. The total involvement includes treatment, surgery, imaging, sample collection, and follow-up evaluations to understand treatment effects and safety.
CONDITIONS
Brief Title
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Research Team
X
Xue Meng, MD, PhD
G
Guoxin Cai, MD
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Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) non-small cell lung cancer
No EGFR, ALK, or ROS1 gene mutations
Eastern Cooperative Oncology Group (ECOG) status 0 to 1
Signed written informed consent before any trial procedures
Adequate organ function based on laboratory tests with no contraindications to chemotherapy, including specified blood counts and liver and kidney function limits
You will not qualify if you...
Diagnosis of any other malignant tumor
Prior treatment with chemotherapy or immune checkpoint inhibitors
Insufficient calorie or fluid intake despite nutritional support
Active infections needing systemic therapy unresolved within 3 to 7 days before treatment
Inability to tolerate chemoradiotherapy or surgery due to severe heart or lung problems
History of interstitial lung disease or non-infectious pneumonia
Active autoimmune disease requiring systemic therapy within the past 2 years
Known HIV or viral hepatitis infection
Previous allogeneic stem cell or solid organ transplantation
Pregnancy or breastfeeding
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Duration of 3 treatment cycles
Participants receive 3 cycles of camrelizumab combined with chemotherapy before surgery.
3 treatment visits for drug administration
Follow-up
Duration - Up to 24 months
Participants are monitored for adverse events and disease-free survival after surgery.
Visits for safety and disease monitoring during follow-up
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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.
Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study.