An Open-label Randomized Phase II Trial of Gemcitabine and Cisplatin With or Without Bevacizumab in EGFR Wild-type Non-squamous Non-small-cell Lung Cancer Patients
Lung cancer is the leading cause of cancer morbidity and mortality worldwide. The majority
of lung cancer is nonsquamous NSCLC. EGFR tyrosine kinase inhibitors (EGFR-TKI) is a
effective first-line treatment for EGFR mutations non-squamous NSCLC treatment. But those
patients without epidermal growth factor receptor (EGFR) mutations show a poorer prognosis.
Gemcitabine combined with cisplatin chemotherapy is an effective treatment measures for EGFR
mutation-negative NSCLC patients, but the prognosis remains poor. Chemotherapy combined with
targeted monoclonal antibody treatment may be better treatment options in these patients.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways.
Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. This
randomized trial studies how well giving cisplatin and gemcitabine alone or in combination
with Bevacizumab (Avastin) works in treating patients with stage IIIB/IV non-squamous NSCLC
without EGFR mutations. Accordingly, we have come to a scientific hypothesis that cisplatin
and gemcitabine combination with Bevacizumab might be a better treatment strategy for stage
IIIB/IV non-squamous NSCLC patients with EGFR wild-type. It can improve the PFS of stage
IIIB/IV non-squamous NSCLC patients with EGFR wild-type. The primary endpoint is
disease-free time to progression (PFS). The secondary study endpoint is objective response
rate (ORR), disease control rate (DCR), safety and quality of life (QOL). Through this study
lay the foundation for further exploration of the non-squamous NSCLC first-line treatment in
patients with EGFR wild-type strategy, and guide the rational application of bevacizumab.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease-free time to progression
juan li, MD
Sichuan Cancer Hospital and Research Institute
China: Ministry of Health