A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)
|ClinicalTrials.gov Identifier: NCT00257608|
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : March 15, 2016
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: bevacizumab Drug: placebo Drug: erlotinib HCl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer|
|Study Start Date :||January 2006|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
Intravenous repeating doseDrug: erlotinib HCl
Oral repeating dose
|Placebo Comparator: 2||
Intravenous repeating doseDrug: placebo
Oral repeating dose
- Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]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.
- Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase [ Time Frame: Approximately 3 years ]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.
- Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase [ Time Frame: Approximately 3 years ]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.
- Number of Participants With Any Adverse Events During Post-Chemotherapy Phase [ Time Frame: Approximately 3.5 years ]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.
- Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase [ Time Frame: Approximately 3 years ]Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).
- Incidence of Study Treatment Discontinuation [ Time Frame: Approximately 3 years ]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.
- Overall Survival [ Time Frame: Approximately 3.5 years ]Overall survival was defined as the length of time from randomization to death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257608
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|Study Director:||Donald Strickland, M.D.||Genentech, Inc.|