Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Neoadjuvant Bevacizumab

• Registration Number: NCT01588704
• Lead Sponsor: Si-Yu Wang

Brief Summary

The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

Detailed Description

This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
• No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
• Adequate organ and bone marrow function

Exclusion Criteria

• Prior chemotherapy or radiation therapy for NSCLC
• Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
• Patients with known hypersensitivity to other recombinant human antibodies
• History of stroke or transient ischemic attack (TIA).
• History of myocardial infarction or unstable angina within the past 12 months.
• Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
• Women who are pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Bevacizumab	Neoadjuvant Bevacizumab	Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.

Primary Outcome Measures

Name	Time	Method
Resectability rate	3 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	2 years
Number of participants with perioperative complications	4 months
Overall survival	2 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China