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dc.contributor.authorGridelli, C
dc.contributor.authorBennouna, J
dc.contributor.authorde Castro, J
dc.contributor.authorDingemans, A
dc.contributor.authorGriesinger, F
dc.contributor.authorGrossi, F
dc.contributor.authorRossi, A
dc.contributor.authorThatcher, Nick
dc.contributor.authorWong, E K
dc.contributor.authorLanger, C
dc.date.accessioned2012-03-20T13:15:14Z
dc.date.available2012-03-20T13:15:14Z
dc.date.issued2011-11
dc.identifier.citationRandomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. 2011, 12 (6):407-11 Clin Lung Canceren_GB
dc.identifier.issn1938-0690
dc.identifier.pmid21705281
dc.identifier.doi10.1016/j.cllc.2011.05.002
dc.identifier.urihttp://hdl.handle.net/10541/216117
dc.description.abstractWe present the treatment rationale and study design of the AvaALL (MO22097; ClinicalTrials: NCT01351415) trial, a multicenter, open-label, randomized, two-arm, phase IIIb study. Patients with advanced non-squamous non-small-cell lung cancer (NSCLC) whose disease has progressed after four to six cycles of first-line treatment with bevacizumab plus a platinum-based doublet and a minimum of two cycles of bevacizumab (monotherapy) maintenance treatment will be randomized in a 1:1 ratio to one of two study arms. Patients treated on arm A will receive bevacizumab 7.5 or 15 mg/kg intravenously (I.V.) on day 1, every 21 days plus, investigator's choice of agents indicated for use in second-line (limited to pemetrexed, docetaxel, or erlotinib) and subsequent lines of treatment. Patients treated on arm B, will receive investigator's choice of agents alone indicated for use in second-line and subsequent lines of treatment, but no further bevacizumab treatment. The primary endpoint of this study is overall survival (OS). Secondary endpoints include the 6-month, 12-month, and 18-month OS rates, progression-free survival, and time to progression at second and third progressive disease (PD), response rate, disease control rates, and duration of response at second and third PD. Additionally, efficacy in the subgroup of patients with adenocarcinoma, and the safety of bevacizumab treatment across multiple lines of treatment will be assessed. Exploratory objectives include assessment of the quality of life through multiple lines of treatment, comparison of the efficacy between Asian and non-Asian patients, and correlation of biomarkers with efficacy outcomes, disease response, and adverse events.
dc.language.isoenen
dc.rightsArchived with thanks to Clinical lung canceren_GB
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntibodies, Monoclonal, Humanized
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshGlutamates
dc.subject.meshGuanine
dc.subject.meshHumans
dc.subject.meshInternational Agencies
dc.subject.meshLung Neoplasms
dc.subject.meshMaintenance Chemotherapy
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Recurrence, Local
dc.subject.meshNeoplasm Staging
dc.subject.meshPlatinum
dc.subject.meshQuality of Life
dc.subject.meshQuinazolines
dc.subject.meshSurvival Rate
dc.subject.meshTaxoids
dc.subject.meshTreatment Outcome
dc.subject.meshYoung Adult
dc.titleRandomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial.en
dc.typeArticleen
dc.contributor.departmentDivision of Medical Oncology, SG Moscati Hospital, Avellino, Italy.en_GB
dc.identifier.journalClinical Lung Canceren_GB
html.description.abstractWe present the treatment rationale and study design of the AvaALL (MO22097; ClinicalTrials: NCT01351415) trial, a multicenter, open-label, randomized, two-arm, phase IIIb study. Patients with advanced non-squamous non-small-cell lung cancer (NSCLC) whose disease has progressed after four to six cycles of first-line treatment with bevacizumab plus a platinum-based doublet and a minimum of two cycles of bevacizumab (monotherapy) maintenance treatment will be randomized in a 1:1 ratio to one of two study arms. Patients treated on arm A will receive bevacizumab 7.5 or 15 mg/kg intravenously (I.V.) on day 1, every 21 days plus, investigator's choice of agents indicated for use in second-line (limited to pemetrexed, docetaxel, or erlotinib) and subsequent lines of treatment. Patients treated on arm B, will receive investigator's choice of agents alone indicated for use in second-line and subsequent lines of treatment, but no further bevacizumab treatment. The primary endpoint of this study is overall survival (OS). Secondary endpoints include the 6-month, 12-month, and 18-month OS rates, progression-free survival, and time to progression at second and third progressive disease (PD), response rate, disease control rates, and duration of response at second and third PD. Additionally, efficacy in the subgroup of patients with adenocarcinoma, and the safety of bevacizumab treatment across multiple lines of treatment will be assessed. Exploratory objectives include assessment of the quality of life through multiple lines of treatment, comparison of the efficacy between Asian and non-Asian patients, and correlation of biomarkers with efficacy outcomes, disease response, and adverse events.


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