Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Lung (Non-Small Cell)

Protocol H3E-MC-JMHD: Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

Unique Data Set IDLungNo_EliLill_2008_141
DownloadableYes
SponsorEli Lilly & CompanyData ProviderEli LillyTotal Study Enrolled Patients939Comparator (Control) Arm Enrolled Patients467RandomizationYesClinicalTrial.gov IDNCT00762034ClinicalTrial.gov URLhttps://www.clinicaltrials.gov/ct2/show/NCT00762034
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

Protocol H3E-MC-JMHD: Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

Trial Summary and Conditions

Study JMHD is a multicenter, randomized, open-label, Phase 3 trial. Eligible patients will be randomized in a 1:1 ratio to 1 of the following treatment arms: Arm A - Pemetrexed, carboplatin, and bevacizumab followed by pemetrexed and bevacizumab (450 patients), Arm B- Paclitaxel, carboplatin, and bevacizumab followed by bevacizumab (450 patients). Patientsrandomized to Arm A will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, patients randomized to Arm B will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommendedin the paclitaxel label. Randomization will be stratified by the following factors: disease stage (IIIB with pleural effusions versus IV), measurable versus nonmeasurable disease, ECOG performance status (0 versus 1), and sex (male versus female).

Data Summary

Datasets include Analysis datasets of control Arm data for efficacy, safety and patient characteristics.

Study Objectives

The primary objective is to compare overall survival (OS) for: Arm A: pemetrexed plus carboplatin plus bevacizumab, followed by maintenance bevacizumab plus 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 IIIB (with pleural effusions) or IV nonsquamous NSCLC. The secondary objectives of the study are as follows: Efficacy: to compare the overall response rates (RRs) and the disease control rates (DCRs), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000), between the 2 treatment arms. to compare the following time-to-event efficacy variables between the 2 treatment arms: progression-free survival (PFS) time to progressive disease (TTPD). 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) to compare hospitalizations, transfusions, and concomitant medication use between the 2 treatment arms. Quality of Life: to evaluate differences in patient-reported outcomes (PROs), as assessed by the Functional Assessment of Cancer Therapy-Lung/Neurotoxicity (FACT-L/Ntx) instrument (Cella et al. 1995; Calhoun et al. 2003) between the 2 treatment arms.

Outcome Measures

Overall survival (OS), overall response rates (RRs), disease control rates (DCRs), progression-free survival (PFS), time to progressive disease (TTPD), safety and Quality of Life using Functional Assessment of Cancer Therapy-Lung/Neurotoxicity (FACT-L/Ntx) instrument.

Available Downloads:

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

PROTOCOL: JMHD 05 Protocol (f).pdf

CRF: JMHD_CRF_redacted.pdf

DATA DICTIONARY: jmhd_specification_final_redacted.pdf

DATA (COMPARATOR ARM): jmhd_deid_control_trt.zip