Randomized 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.
dc.contributor.author | Gridelli, C | |
dc.contributor.author | Bennouna, J | |
dc.contributor.author | de Castro, J | |
dc.contributor.author | Dingemans, A | |
dc.contributor.author | Griesinger, F | |
dc.contributor.author | Grossi, F | |
dc.contributor.author | Rossi, A | |
dc.contributor.author | Thatcher, Nick | |
dc.contributor.author | Wong, E K | |
dc.contributor.author | Langer, C | |
dc.date.accessioned | 2012-03-20T13:15:14Z | |
dc.date.available | 2012-03-20T13:15:14Z | |
dc.date.issued | 2011-11 | |
dc.identifier.citation | Randomized 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 Cancer | en_GB |
dc.identifier.issn | 1938-0690 | |
dc.identifier.pmid | 21705281 | |
dc.identifier.doi | 10.1016/j.cllc.2011.05.002 | |
dc.identifier.uri | http://hdl.handle.net/10541/216117 | |
dc.description.abstract | We 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.iso | en | en |
dc.rights | Archived with thanks to Clinical lung cancer | en_GB |
dc.subject.mesh | Adolescent | |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Aged, 80 and over | |
dc.subject.mesh | Antibodies, Monoclonal, Humanized | |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung | |
dc.subject.mesh | Female | |
dc.subject.mesh | Follow-Up Studies | |
dc.subject.mesh | Glutamates | |
dc.subject.mesh | Guanine | |
dc.subject.mesh | Humans | |
dc.subject.mesh | International Agencies | |
dc.subject.mesh | Lung Neoplasms | |
dc.subject.mesh | Maintenance Chemotherapy | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Neoplasm Recurrence, Local | |
dc.subject.mesh | Neoplasm Staging | |
dc.subject.mesh | Platinum | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Quinazolines | |
dc.subject.mesh | Survival Rate | |
dc.subject.mesh | Taxoids | |
dc.subject.mesh | Treatment Outcome | |
dc.subject.mesh | Young Adult | |
dc.title | Randomized 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.type | Article | en |
dc.contributor.department | Division of Medical Oncology, SG Moscati Hospital, Avellino, Italy. | en_GB |
dc.identifier.journal | Clinical Lung Cancer | en_GB |
html.description.abstract | We 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. |
Files in this item
This item appears in the following Collection(s)
-
All Christie Publications
-
Medical Oncology
Medical Oncology