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Lung (Non-Small Cell)

A multinational, randomized, double-blind study comparing aflibercept versus placebo in patients treated with second-line docetaxel after failure of one platinum based therapy for locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Unique Data Set IDLungNo_SanofiU_2007_133
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients913Comparator (Control) Arm Enrolled Patients455RandomizationYesClinicalTrial.gov IDNCT00532155ClinicalTrial.gov URLhttp://ClinicalTrials.gov/show/NCT00532155
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlacebo, Chemotherapy, DrugData Set TypeSDTM

Clinical Trial Title

A multinational, randomized, double-blind study comparing aflibercept versus placebo in patients treated with second-line docetaxel after failure of one platinum based therapy for locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Trial Summary and Conditions

This is a prospective, multicenter, multinational, randomized (1:1), double-blind, parallel-group study comparing the efficacy in term of overall survival (OS) of aflibercept (Arm A) versus placebo (Arm B) administered on top of the standard docetaxel regimen as secondline treatment for patients with NSCLC. Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal.

Data Summary

Datasets contain 455* de-identified subjects that were randomized to the placebo control arm (453 treated, 2 not treated). Data elements include: demographic, adverse events, cancer diagnosis, concomitant medications, control arm exposure, inclusion/exclusion criteria, laboratory data, medical history, radio and surgical interventions, vital signs, tobacco usage, quality of life questionnaires, ECG assessments, Tumor measurement and response data and study milestone events. *Note that a total of 457 subjects were randomized to a planned treatment arm of Placebo, however 2 of these subjects were given Aflibercept. These 2 patients were therefore excluded from all the de-identified datasets, bringing the total patient count down to 455.

Study Objectives

Primary objectives: To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) Secondary objectives: - To compare efficacy of aflibercept to placebo for: - Progression Free Survival (PFS), - Response Rate (RR) as per RECIST criteria (JNCI 2000), - Health Related Quality of Life (HRQL) assessed by the Lung cancer symptom scale (LCSS) questionnaire - To assess the overall safety of the two treatment groups. - To assess the pharmacokinetics of intravenous (IV) aflibercept in this patient population. - To determine immunogenicity of IV aflibercept (anti- aflibercept antibody detection) in all patients

Outcome Measures

Efficacy: The primary efficacy endpoint was OS, defined as the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, OS time was censored at the last date the patient was known to be alive, or the study cutoff date, whichever was earlier. Secondary efficacy endpoints included PFS, objective responses (complete response [CR] and partial response [PR]) as assessed by investigators according to RECIST (version 1.0) criteria (for patients with measurable disease at study entry) and health-related quality of life (HRQL) performed using the Lung Cancer Symptom Scale (LCSS) questionnaire. Safety: Safety and tolerability were assessed through the collection of adverse events (AEs), laboratory data (hematology, chemistry, and urinalysis), vital signs, physical exam, Eastern Cooperative Oncology Group (ECOG) performance status, and immunogenicity (assay for positive or negative antiaflibercept antibodies).

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_AVE0005_efc10261_protocol_redacted.pdf

CRF: sanofi_AVE0005_efc10261_crf_redacted.pdf

DATA DICTIONARY: sanofi_ave0005_efc10261_data_definition.xls

DATA (COMPARATOR ARM): sanofi_AVE0005_EFC10261_datasets_and readme.zip