Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00102804
Last Updated: 2014-12-29
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
663 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-03-31
Study Completion Date
2013-12-31
Brief Summary
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This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.
Detailed Description
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Conditions
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Non-Small Cell Lung Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Pemetrexed and Best Supportive Care
Group Type
EXPERIMENTAL
Pemetrexed
Intervention Type
DRUG
500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression
Best Supportive Care
Intervention Type
OTHER
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
Placebo and Best Supportive Care
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
IV administration, q 21 days
Best Supportive Care
Intervention Type
OTHER
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
Interventions
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Pemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression
Intervention Type
DRUG
Placebo
IV administration, q 21 days
Intervention Type
DRUG
Best Supportive Care
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
Intervention Type
OTHER
Other Intervention Names
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LY231514
Alimta
Eligibility Criteria
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Inclusion Criteria
* Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.
* Participants must have had 1 of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.
* Participants must have received only 1 chemotherapeutic doublet lasting precisely 4 cycles.
* Induction regimens must be based on 21-day cycles.
* Documented evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the participant to be randomized. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.
* Participants must have had 1 of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.
* Participants must have received only 1 chemotherapeutic doublet lasting precisely 4 cycles.
* Induction regimens must be based on 21-day cycles.
* Documented evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the participant to be randomized. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.
Exclusion Criteria
* With the exception of those chemotherapies listed as inclusion criterion, participants will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.
* 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.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that would compromise the participant's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
* 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.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that would compromise the participant's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Minneapolis, Minnesota, United States
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Portsmouth, New Hampshire, United States
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Pittsburgh, Pennsylvania, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Marshfield, Wisconsin, United States
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Bankstown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Nambour, Queensland, Australia
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Townsville, Queensland, Australia
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Ashford, South Australia, Australia
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Frankston, Victoria, Australia
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Vienna, , Austria
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Ijuí, , Brazil
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São Paulo, , Brazil
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Beijing, , China
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Dalian, , China
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Guangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Nanjing, , China
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Shanghai, , China
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Zagreb, , Croatia
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Brno, , Czechia
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Ostrava-Poruba, , Czechia
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Prague, , Czechia
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Hamburg, , Germany
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Hamm, , Germany
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Hanover, , Germany
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Magdeburg, , Germany
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Ulm, , Germany
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Athens, , Greece
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Chania, , Greece
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Mosdós, , Hungary
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Szombathely, , Hungary
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Banglagore, , India
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Jaipur, , India
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Mumbai, , India
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P.O Ernakulam, , India
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Trivandrum, , India
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Bari, , Italy
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Bologna, , Italy
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Genova, , Italy
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Livorno, , Italy
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Messina, , Italy
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Padua, , Italy
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Pisa, , Italy
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Rome, , Italy
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Rozzano, , Italy
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Amsterdam, , Netherlands
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Ede, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Poznan, , Poland
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Warsaw, , Poland
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Cluj-Napoca, , Romania
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Oradea, , Romania
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Seoul, , South Korea
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Alcorcón, , Spain
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Alcoy, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Mataró, , Spain
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Murcia, , Spain
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Palma de Mallorca, , Spain
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Santa Cruz de Tenerife, , Spain
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Countries
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United States
Australia
Austria
Brazil
Bulgaria
China
Croatia
Czechia
Germany
Greece
Hungary
India
Italy
Netherlands
Poland
Romania
South Korea
Spain
Taiwan
Turkey (Türkiye)
References
Explore related publications, articles, or registry entries linked to this study.
Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.
Reference Type
DERIVED
Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
Reference Type
DERIVED
Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H3E-MC-JMEN
Identifier Type: OTHER
Identifier Source: secondary_id
5122
Identifier Type: -
Identifier Source: org_study_id