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Lung (Non-Small Cell)

A multicenter randomized double blind placebo-controlled phase 3 efficacy and safety study of sunitinib in patients with advanced/metastatic non-small cell lung cancer treated with erlotinib

Unique Data Set IDLungNo_Pfizer_2007_115
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients960Comparator (Control) Arm Enrolled Patients480RandomizationYesClinicalTrial.gov IDNCT00457392ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00457392?term=NCT00457392&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A multicenter randomized double blind placebo-controlled phase 3 efficacy and safety study of sunitinib in patients with advanced/metastatic non-small cell lung cancer treated with erlotinib

Trial Summary and Conditions

Patients previously treated with one to two chemotherapy regimens (including one platinum-based regimen) for recurrent NSCLC, and for whom erlotinib was indicated, were randomly assigned (1:1) to sunitinib 37.5 mg/d plus erlotinib 150 mg/d or to placebo plus erlotinib 150 mg/d, stratified by prior bevacizumab use, smoking history, and epidermal growth factor receptor expression.

Data Summary

Median OS was 9.0 months for sunitinib plus erlotinib versus 8.5 months for erlotinib alone (hazard ratio [HR], 0.922; 95% CI, 0.797 to 1.067; one-sided stratified log-rank P = .1388). Median PFS was 3.6 months versus 2.0 months (HR, 0.807; 95% CI, 0.695 to 0.937; one-sided stratified log-rank P = .0023), and ORR was 10.6% versus 6.9% (two-sided stratified log-rank P = .0471), respectively. Treatment-related toxicities of grade 3 or higher, including rash/dermatitis, diarrhea, and asthenia/fatigue were more frequent in the sunitinib plus erlotinib arm.

Study Objectives

The primary end point was OS. Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.

Outcome Measures

N/A

Available Downloads:

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

PROTOCOL: A6181087 Final Protocol 14 MAR 2007.pdf

CRF: Sample-case-report-form_A6181087_Final_Version11_11-APR-2011.pdf

DATA DICTIONARY: A6181087_SPECS.xlsx

DATA (COMPARATOR ARM): adverse.sas7bdat

DATA (COMPARATOR ARM): cd_b_p.sas7bdat

DATA (COMPARATOR ARM): cn_6_p.sas7bdat

DATA (COMPARATOR ARM): cn_7_p.sas7bdat

DATA (COMPARATOR ARM): cn_8_p.sas7bdat

DATA (COMPARATOR ARM): condrug.sas7bdat

DATA (COMPARATOR ARM): contrt.sas7bdat

DATA (COMPARATOR ARM): demog.sas7bdat

DATA (COMPARATOR ARM): ecg.sas7bdat

DATA (COMPARATOR ARM): final.sas7bdat

DATA (COMPARATOR ARM): iota_p.sas7bdat

DATA (COMPARATOR ARM): lab_safe.sas7bdat

DATA (COMPARATOR ARM): pfm_p.sas7bdat

DATA (COMPARATOR ARM): phyexam.sas7bdat

DATA (COMPARATOR ARM): prevdis.sas7bdat

DATA (COMPARATOR ARM): primdiag.sas7bdat

DATA (COMPARATOR ARM): random.sas7bdat

DATA (COMPARATOR ARM): testdrug.sas7bdat

DATA (COMPARATOR ARM): tmm_p.sas7bdat

DATA (COMPARATOR ARM): vitals.sas7bdat