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Lung (Non-Small Cell)

A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared with Taxol and Carboplatin as First-line Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Unique Data Set IDLungNo_Celgene_2007_108
DownloadableYes
SponsorCelgene CorporationData ProviderCelgeneTotal Study Enrolled Patients1052Comparator (Control) Arm Enrolled Patients524RandomizationYesClinicalTrial.gov IDNCT00540514ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00540514?term=NCT00540514&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared with Taxol and Carboplatin as First-line Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This is a controlled, randomized, multicenter, Phase III study to evaluate the safety/tolerability and anti-tumor effect of intravenously administered ABI-007/carboplatin combination therapy compared to that of Taxol/carboplatin combination therapy as first-line therapy in patients with NSCLC.

Data Summary

All data collected are from the comparator arm. This de-identified data set represents 524 patients enrolled from an FDA-approved comparator treatment arm: solvent-bound paclitaxel + carboplatin. A total of 1052 patients were accrued to the study globally.

Study Objectives

To evaluate the safety and efficacy of 100 mg/m2 30-minute infusion of nab-paclitaxel on days 1, 8, and 15 followed by carboplatinAUC6mg/mL/min(per Calvert formula)19 on day 1 every 3 weeks (nab-PC) compared with 200 mg/m2 3-hour infusion of sb-paclitaxel plus carboplatin at AUC 6 (sb-PC), both given every 3 weeks, as first-line therapy in patients with advanced NSCLC

Outcome Measures

Primary: Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment. Antitumor response was defined as the percentage of participants who achieved an objective response, confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. \nA complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as > 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).

Available Downloads:

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

PROTOCOL: CA031 NSCLC Protocol.pdf

CRF: CA031 NSCLC CRF.pdf

DATA DICTIONARY: CA031 Data Dictionary Placeholder.docx

DATA (COMPARATOR ARM): CA031 NCSLC Data Files.zip