A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130728
• Other study ID #: OSI3364g
• Status: Completed
• Phase: Phase 3
• Start date: June 8, 2005
• Est. completion date: December 23, 2019

Study information

• Verified date: December 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: December 23, 2019
• Est. primary completion date: July 15, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent
• Cytologically or histologically confirmed NSCLC
• Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
• Consent to provide archival tissue for analysis is required for participation in this study
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Age = 18 years
• Use of an acceptable means of contraception for men and women of childbearing potential
• International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to enrollment for patients not on low-molecular-weight heparin or fondaparinux

Exclusion Criteria:

• Squamous cell carcinoma
• Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth Factor Receptor (EGFR) pathway or anti-angiogenesis agent
• Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
• Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
• Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
• Neurosurgery for brain metastases within 24 weeks of Day 0
• Brain biopsy within 12 weeks of Day 0
• Current use of dexamethasone for treatment associated with brain metastases
• History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
• History of any of the following within 6 months prior to Day 0: serious systemic disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
• Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
• Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
• Progressive neurologic symptoms in patients with a history of brain metastases
• Full-dose anticoagulation with warfarin
• Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-platelet activity
• In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
• Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
• Anticipation of need for a major surgical procedure during the course of the study
• Serious, non-healing wound, ulcer, or bone fracture
• Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
• Pregnancy or breast-feeding
• Presence of another invasive cancer within 5 years prior to randomization
• Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• bevacizumab
intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
• erlotinib HCl
oral erlotinib HCl 150 mg/day orally
• placebo
intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Locations

Country	Name	City	State
United States	Anne Arundel Health System Research Instit-Annapolis Oncology Ctr	Annapolis	Maryland
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Kaiser Permanente - Vallejo	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) Among All Randomized Patients	Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.	From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Secondary	Progression-free Survival (PFS)	PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.	From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)
Secondary	Percentage of Participants With Objective Response	Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.	The median duration of Objective response was up to 9.7 months
Secondary	Duration of Objective Response	Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.	Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)