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Lung (Non-Small Cell)

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemo-naive patients with Stage IIIB-IV non-small cell lung cancer (NSCLC) (ESCAPE) (ClinicalTrials.gov Identifier: NCT 00300885)

Unique Dataset IDLungNo_BayerAG_2006_274
DownloadableNo
SponsorBayer HealthCare Pharmaceuticals Inc.Data ProviderBayer HealthCare Pharmaceuticals Inc.Total Study Enrolled Patients926Comparator (Control) Arm Enrolled Patients462RandomizationYesClinicalTrial.gov IDNCT00300885ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00300885
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemo-naive patients with Stage IIIB-IV non-small cell lung cancer (NSCLC) (ESCAPE) (ClinicalTrials.gov Identifier: NCT 00300885)

Trial Summary and Conditions

This study was conducted to evaluate safety and efficacy of carboplatin and paclitaxel in combination with sorafenib versus placebo, in chemo-naive patients with unresectable stage IIIB (with pleural or pericardial effusion) or Stage IV non-small cell lung cancer. Patients received chemotherapy up to 6 cycles: Sorafenib 400 mg orally, twice daily (or placebo) on Study Days 2-19 and paclitaxel (P) (200 mg/m2, IV) and carboplatin (C) (AUC = 6 mg/ml*min-1, IV) on Study Day 1. The cycle duration is 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily (or placebo) was administered on Days 1-21 of each 21-day cycle.

Data Summary

SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, with Bayer legacy data standard, Some data sets have been modified or eliminated in accordance with Bayer Anonymization procedures prior to release to Project Data Sphere.

Study Objectives

o Primary objective: overall survival (OS) o Secondary objectives: tumor response, duration of response, progression free survival and patient reported outcome (PRO) o Other objectives: evaluation of biomarkers that may relate to the pharmacological mechanism of action of sorafenib to its antitumor activity

Outcome Measures

All randomized patients will be followed for survival information. Patient deaths occurring during study will be recorded in the CRF. After the discontinuation of study drug treatment, patients will be placed into the Post Treatment Follow-up phase of the trial. Tumor response and disease progression will be evaluated based on investigator assessed RECIST tumor response criteria.

Available Downloads:

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

PROTOCOL: Bayer_11961_ESCAPE_protocol.pdf

CRF: Bayer_11961_ESCAPE_anno_CRF.pdf

DATA DICTIONARY: pds_oad_specifications_v1.0.xls

DATA (COMPARATOR ARM): 11961_datasets.zip