This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,145
Intravenous repeating dose
Oral repeating dose
Oral repeating dose
Progression-free Survival (PFS)
PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.
Time frame: Approximately 3 years
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase
Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade \>=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.
Time frame: Approximately 3 years
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase
Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade \>=3. Data presented until cut-off date 28 January 2009.
Time frame: Approximately 3 years
Number of Participants With Any Adverse Events During Post-Chemotherapy Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.
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Sacred Heart Medical Onc Group
Mobile, Alabama, United States
St. Edward Mercy Medical Ctr
Fort Smith, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Central Hem/Onc Medical Group
Alhambra, California, United States
Comp Blood & Cancer Center
Bakersfield, California, United States
South Bay Oncology
Campbell, California, United States
Bay Area Cancer Research Grp
Concord, California, United States
Pacific Onc & Hem Assoc
Encinitas, California, United States
Pacific Coast Hem/Onc
Fountain Valley, California, United States
...and 237 more locations
Time frame: Approximately 3.5 years
Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase
Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).
Time frame: Approximately 3 years
Incidence of Study Treatment Discontinuation
Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.
Time frame: Approximately 3 years
Overall Survival
Overall survival was defined as the length of time from randomization to death.
Time frame: Approximately 3.5 years