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Lung (Small Cell)

Randomized Phase 3 Trial of ALIMTA (Pemetrexed) and Carboplatin versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Unique Data Set IDLungNo_ELiLill_2006_116
DownloadableYes
SponsorEli Lilly & CompanyData ProviderEli LillyTotal Study Enrolled Patients908Comparator (Control) Arm Enrolled Patients455RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

Randomized Phase 3 Trial of ALIMTA (Pemetrexed) and Carboplatin versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Trial Summary and Conditions

Study H3E-MC-JMHO (JMHO) is a Phase 3, global, multicenter, randomized, open-label study of approximately 1820 patients with ED-SCLC. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin (experimental treatment, Arm A) or etoposide plus carboplatin (control treatment, Arm B). Randomization factors include Eastern Oncology Cooperative Group (ECOG) performance status, lactate dehydrogenase (LDH), number of metastases, history of brain metastases, age, gender, and investigative center. The primary endpoint of this study was overall survival (OS). Note, due to the study stopping early prior to completion of enrollment, the number of patients randomized is less than the number planned 1820 patients (910 patient per Arm). Hence there are 455 patients in the database for Control arm.

Data Summary

Control arm data files include analysis data sets on safety, efficacy, demographics, concomitant therapy,vital signs, medical history, treatment exposure, etc.

Study Objectives

The primary objective of the study is to compare the overall survival of previously untreated patients with ED-SCLC after treatment with pemetrexed plus carboplatin versus etoposide plus carboplatin. The secondary objectives of the study are to assess and compare the following variables between treatment arms: - overall survival among a subgroup of patients classified as ?sensitive? with respect to the results of a prospectively defined set of biomolecular assays -time-to-event variables, including: - objective progression-free survival (PFS) - survival without Grade 4 toxicity (G4 SWT) - survival without Grade 3-4 toxicity (G3-4 SWT) - time to worsening of HRQoL (health-related quality of life) (TWQ) - objective tumor response - time-to-event variables and objective tumor response among the subgroup of patients classified as ?sensitive? with respect to the results of a prospectively defined set of biomolecular assays -changes in dimensions of HRQoL - the safety and adverse event profile (including Common Terminology Criteria for Adverse Events [CTCAE Version 3.0,

Outcome Measures

Outcome measures are: overall survival, objective progression-free survival (PFS), survival without Grade 4 toxicity (G4 SWT), survival without Grade 3-4 toxicity (G3-4 SWT), time to worsening of HRQoL (health-related quality of life) (TWQ), objective tumor response, changes in dimensions of HRQoL, the safety and adverse event profile (including Common Terminology Criteria for Adverse Events [CTCAE Version 3.0

Available Downloads:

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

PROTOCOL: JMHO_protocol(b).pdf

CRF: JMHO_CRFs.pdf

DATA DICTIONARY: JMHO Data Def ADSRequirementFinal(01AUG08_03_29).pdf

DATA (COMPARATOR ARM): jmho_deid_control_trt.zip