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Phase 2
Age: 18Years - 75Years
All Genders
ID06241807

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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