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Lung (Non-Small Cell)

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) (NEXUS) (ClinicalTrials.gov Identifier: NCT00449033)

Unique Dataset IDLungNo_BayerAG_2007_275
DownloadableNo
SponsorBayer HealthCare Pharmaceuticals Inc.Data ProviderBayer HealthCare Pharmaceuticals Inc.Total Study Enrolled Patients904Comparator (Control) Arm Enrolled Patients452RandomizationYesClinicalTrial.gov IDNCT00449033ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00449033
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, PlaceboDataset TypeOther

Clinical Trial Title

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) (NEXUS) (ClinicalTrials.gov Identifier: NCT00449033)

Trial Summary and Conditions

This study was conducted to evaluate the efficacy and safety of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin, as the first-line treatment of patients with stage IIIB (with effusion) or Stage IV NSCLC, with ECOG performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy. Patients received up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib, or placebo. Day 1: gemcitabine 1250 mg/m2 infusion (IV), followed by cisplatin 75 mg/ m2 IV; Day 8: gemcitabine 1250 mg/m2 IV; Days 1-21: sorafenib 2 tablets (200 mg x 2) taken orally twice daily (BID), or placebo.

Data Summary

SAS data sets representing control arm patients including raw data on safety, efficacy, demographics, in 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: progression-free survival (PFS) o Secondary objectives: overall survival, tumor response, time to progression, lung cancer symptom response, disease control rate, duration of response, duration of stable disease, safety and toxicity of the combination treatment, and health-related quality of life (HRQOL) o Other objectives: Evaluation of biomarkers that may relate to the pharmacological mechanism of action of sorafenib to its antitumor activity

Outcome Measures

The primary efficacy variable is progression-free survival. Secondary efficacy variables include overall survival, tumor response, time to progression, lung cancer symptom response, disease control rate, duration of response, duration of stable disease, and HRQOL. Tumor response and disease progression will be evaluated based on RECIST tumor response criteria (see Appendix I03). Measurements will be made at baseline and then every 2 cycles (6 weeks) during the treatment period until progressive disease is documented, and also at the end of treatment visit if applicable.

Available Downloads:

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

PROTOCOL: Bayer_12006_NEXUS_protocol.pdf

CRF: Bayer_12006_NEXUS_annotated_CRF.pdf

DATA DICTIONARY: pds_oad_specifications_v1.0.xls

DATA (COMPARATOR ARM): Bayer_12006_NEXUS_datasets.zip