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Lung (Non-Small Cell)
Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell HistologyUnique Data Set IDLungNo_EliLill_2008_148
Clinical Trial Title
Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology
Trial Summary and Conditions
Study H3E-MC-JMIG (JMIG) is a multicenter, randomized, open-label, Phase 3 trial of patients with locally advanced, unresectable/inoperable, Stage III NSCLC other than predominantly squamous cell histology (nonsquamous) without malignant pleural/pericardial effusion. Approximately 600 patients will be randomized. Randomization will be at a 1:1 ratio between the experimental arm (Arm A; pemetrexed, cisplatin, and concurrent TRT for 3 cycles, followed by consolidation pemetrexed for 4 cycles), and the control arm (Arm B; etoposide, cisplatin, and concurrent TRT for 2 cycles, followed by consolidation with cytotoxic platinum-based doublet regimen of choice [excluding pemetrexed] for a maximum of 2 cycles). Concurrent chemoradiotherapy cycles are 21 days for Arm A, and 28 days for Arm B. Patients will be evenly randomized to treatment arms using an Interactive Voice Response System (IVRS) at a central location. The IVRS will assign patients to treatment arms according to a stratified method of randomization. In other words, there will be a separate and independent randomization within each of 16 strata or subgroups, defined by all 16 combinations of values of the following prognostic factors: ? Baseline ECOG performance status (0 versus 1) ? Gender (female versus male) ? Stage of disease (IIIA versus IIIB) ? PET scan (yes versus no).
Control arm data on demographics, safety, efficacy, treatment exposure, concomitant medications, medical history, and labs
Primary Objective: To compare the overall survival (OS) of patients with locally advanced, Stage III NSCLC other than predominantly squamous cell histology (hereafter referred to as nonsquamous) treated with pemetrexed plus cisplatin and concurrent TRT, followed by consolidation chemotherapy with pemetrexed (Arm A) versus etoposide plus cisplatin and concurrent TRT, followed by consolidation with cytotoxic chemotherapy of choice (Arm B). The secondary objectives are: ?- to compare progression-free survival (PFS) between the 2 arms ? -to compare the first sites of disease failure in terms of relapse: within the radiation treatment field; intrathoracic out of field; distant disease; or some combination of these between the 2 arms ? -to compare the objective response rate (complete response [CR] + partial response [PR]) between the 2 arms ? -to compare 1-, 2-, and 3-year absolute survival rates between the 2 arms ? -to assess patient-reported outcomes (PROs) between the 2 arms using a swallowing diary -to estimate the incidence of adverse events from each treatment arm (acute and late toxicity)
Overall Survival, Progression-free survival (PFS), the first sites of disease failure, Objective response rate, swallowing diary, and incidence of adverse events.
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PROTOCOL: JMIG Protocol.pdf
DATA DICTIONARY: JMIG_ADS_Requirements_Final_Post_Prd1_Redacted.pdf
DATA (COMPARATOR ARM): JMIG_control_data.zip