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Type(s) of Cancer
Lung
Study Phase
Phase 3
Study Completion Date
2009
N/AUploaded 12-07-2020
Available for Download
PDS UID: LungNo_EliLill_2009_438
Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
Provider Information
Provider Data DescriptionThe primary objective is to compare progression-free survival without grade 4 toxicity (G4PFS) according to Common Terminology Criteria for Adverse Events (CTCAE) for the following: Arm A: pemetrexed plus carboplatin, followed by maintenance pemetrexed, Arm B: paclitaxel plus carboplatin plus bevacizumab, followed by maintenance bevacizumab. in the first-line induction and maintenance therapy for the treatment of patients with Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria (AJCC) version 7, including both M1a and M1b disease (Goldstraw 2009; Rami- Porta 2009). The secondary objectives of the study are as follows: Efficacy: to compare PFS between the 2 treatment arms; to compare overall survival between the 2 treatment arms; to compare the overall response rates (ORRs) and the disease control rates (DCRs), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al. 2000), between treatment arms; Safety: to examine the safety and toxicity profile of study treatments, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (NCI 2006).
SponsorEli Lilly
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset361
# of Patients Control179
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/fv7a-0v28
CDISC StandardADS
Study ArmsComparator arm data only
Files:
PROTOCOLS130_Protocol_Redacted.pdf
CRFS130_CRF_redacted.pdf
DATA DICTIONARYS130_ads_requirement_redacted.pdf
DATA SUMMARYDescriptive_Stats_H3E_US_S130.xlsx
DATA SUMMARYProc Contents Data Dictionary H3E_US_S130.pdf
DATA (COMPARATOR ARM)h3e_us_s130_control_data.zip
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