Condition
Non Small Cell Lung Cancer
Estimated Enrollment: 63
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: 13797|I2I-MC-JMMG
Study First Received: June 1, 2010
Last Updated: September 5, 2014
Estimated Primary Completion Date: May 2013
Primary Outcome Measures:
Phase 2: Progression Free Survival Time|Phase 1: Recommended Phase 2 Dose of LY2603618|Phase 2: Overall Survival|Phase 2: Overall Tumor Response Rate: Percentage of Participants who Achieved a Confirmed Best Response of Completed Response (CR) or Partial Response (PR)|Phase 2: Change in Tumor Size|Phase 1: Pharmacokinetic: Maximum Concentration (Cmax) (Pemetrexed, Cisplatin and LY2603618)|Phase 1: Pharmacokinetic: Area Under the Curve (AUC) (Pemetrexed,Cisplatin and LY2603618)|Phase 2: Pharmacokinetic: Maximum Concentration (Cmax) (LY2603618)|Phase2: Pharmacokinetic: Area Under the Curve (AUC) (LY2603618)|Phase 2: Change from Baseline to Long Term Follow-Up in Lung Cancer Symptom Scale (LCSS)|Phase 1: Document any antitumor activity per radiological scans and/or tumor markers|Phase 2: Proportion of Participants Receiving Maintenance Therapy|Phase 2: Clinical Benefit Rate: Percentage of Participant who Achieved a Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR)
Sponsors and Collaborators:
Eli Lilly and Company
Website Link: https://ClinicalTrials.gov/show/NCT01139775
