Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments pemetrexed, cisplatin
Phase phase 2
Sponsor Eli Lilly and Company
Start date November 2010
End date July 2013
Trial size 19 participants
Trial identifier NCT01165021, 13621, H3E-EW-JMIP

Summary

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pemetrexed Alimta
500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
cisplatin
75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

Primary Outcomes

Measure
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy

Secondary Outcomes

Measure
Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]
time frame: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)
Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0
time frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
Overall Survival (OS)
time frame: Enrollment until the date of death from any cause up to 30.5 months
Progression-Free Survival (PFS)
time frame: Enrollment until the first date of objectively determined PD or death up to 30.3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy - Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2) - Tumor considered potentially resectable - Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG) - No prior therapy for lung cancer - Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria - Life expectancy of at least 6 months - Organs are functioning well (bone marrow reserve, liver, kidney, lung) - Signed Informed Consent - Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding. - Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug. - Be fit for surgery at the time of enrollment Exclusion Criteria: - Receiving or have received an investigational drug or device within the last 30 days - Have previously completed or withdrawn from this study or any other study investigating pemetrexed - Serious concomitant systemic disorder - Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease - Receiving concurrent administration of any other anticancer therapy - Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination - Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids) - Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day

Additional Information

Official title An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.