NCT01623102

Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor (EGFR) mutations show a poor 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. It is not yet known whether cisplatin and gemcitabine is more effective when given alone or with bevacizumab. 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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin and gemcitabine combination with Bevacizumab	Patients receive gemcitabine and cisplatin chemotherapy combined with Bevacizumab every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, cisplatin 75mg/m2 d1, Bevacizumab 7.5 mg / kg every 21 days.
DRUG	Gemcitabine combined with cisplatin chemotherapy	Patients receive gemcitabine combined with cisplatin chemotherapy every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, + cisplatin 75mg/m2 d1.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2012-06-19
• Last updated: 2013-02-12

Locations

2 sites across 1 country: China