A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Carcinoma	Drug: pemetrexed; Drug: gemcitabine; Drug: cisplatin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1713 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date :	July 2004
Actual Primary Completion Date :	January 2007
Actual Study Completion Date :	March 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: A	Drug: pemetrexed; 500 mg/m2, IV q 21 days x 6 cycles; Other Names: LY231514; Alimta Drug: cisplatin; 75 mg/m2, IV, q 21 days x 6 cycles
Active Comparator: B	Drug: gemcitabine; 1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles; Other Names: LY188011; Gemzar Drug: cisplatin; 75 mg/m2, IV, q 21 days x 6 cycles

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Overall survival [ Time Frame: baseline to date of death from any cause ]

Secondary Outcome Measures :

1. Progression free survival [ Time Frame: baseline to measured progressive disease ]
2. Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
3. Duration of response [ Time Frame: time of response to progressive disease ]
4. Time to treatment failure [ Time Frame: baseline to stopping treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
• No prior chemotherapy for lung cancer.
• Patients must have at least one uni-dimensionally measurable lesion.
• Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

• Treatment with any drug within the last 30 days that has not received regulatory approval.
• Serious cardiac condition.
• Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
• Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
• Presence of fluid retention that cannot be controlled by drainage.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 134 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information

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Additional Information:

Lilly Clinical Trial Registry 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.

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.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00087711 History of Changes
Other Study ID Numbers:	2938; H3E-MC-JMDB ( Other Identifier: Eli Lilly and Company )
First Posted:	July 16, 2004
Last Update Posted:	November 22, 2016
Last Verified:	November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Cisplatin; Pemetrexed	Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors