Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2005-05-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs
Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
pemetrexed
500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
cisplatin
75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
Radical Non-Small Cell Lung Cancer (NSCLC) surgery
All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
Interventions
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pemetrexed
500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
cisplatin
75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
Radical Non-Small Cell Lung Cancer (NSCLC) surgery
All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* tumor must be accessible by bronchoscopy for tumor tissue sample collection
* patients must have lung cancer with clinical stage IB, II, IIIA
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)
Exclusion Criteria
* pregnant or breast feeding patients
* patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
* unwillingness to take folic acid or vitamin B12 supplementation
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/ GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bystra, , Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poznan, , Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw, , Poland
Countries
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Other Identifiers
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H3E-PL-S051
Identifier Type: OTHER
Identifier Source: secondary_id
9356
Identifier Type: -
Identifier Source: org_study_id