Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00321308 |
Recruitment Status :
Terminated
(See Termination Reason in Detailed Description.)
First Posted : May 3, 2006
Last Update Posted : September 28, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small Cell Lung | Drug: pemetrexed Drug: pemetrexed + PF-3512676 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: B
Standard of care chemotherapy
|
Drug: pemetrexed
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Other Name: Alimta |
Experimental: A
Standard of care chemotherapy plus experimental intervention (PF-3512676)
|
Drug: pemetrexed + PF-3512676
pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Other Name: Alimta |
- Progression-free survival [ Time Frame: 110 Events ]
- Overall Survival [ Time Frame: Time of death ]
- Overall Safety Profile [ Time Frame: 28 days post treatment ]
- Patient Reported Outcome [ Time Frame: End of Treatment ]
- Time to Tumor Progression [ Time Frame: End of treatment ]
- Overall Objective Response Rate [ Time Frame: Time of disease progressive disease ]
- Duration of Response [ Time Frame: Time of disease progression ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Locally advanced or metastatic NSCLC
- Measurable disease
- ECOG PS 0 or 1
Exclusion Criteria:
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321308
United States, Arizona | |
Pfizer Investigational Site | |
Litchfield Park, Arizona, United States, 85340 | |
Pfizer Investigational Site | |
Sun City, Arizona, United States, 85351 | |
United States, Arkansas | |
Pfizer Investigational Site | |
Bentonville, Arkansas, United States, 72712 | |
Pfizer Investigational Site | |
Fayetteville, Arkansas, United States, 72703 | |
United States, Florida | |
Pfizer Investigational Site | |
Hudson, Florida, United States, 34667 | |
Pfizer Investigational Site | |
New Port Richey, Florida, United States, 34655 | |
United States, New Jersey | |
Pfizer Investigational Site | |
Mahwah, New Jersey, United States, 07430 | |
Pfizer Investigational Site | |
Midland Park, New Jersey, United States, 07432 | |
Pfizer Investigational Site | |
Paramus, New Jersey, United States, 07652 | |
Pfizer Investigational Site | |
Westwood, New Jersey, United States, 07675 | |
United States, New York | |
Pfizer Investigational Site | |
Oneida, New York, United States, 13421 | |
Pfizer Investigational Site | |
Oswego, New York, United States, 13126 | |
Pfizer Investigational Site | |
Syracuse, New York, United States, 13210-2306 | |
Pfizer Investigational Site | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Pfizer Investigational Site | |
Sylvania, Ohio, United States, 43560 | |
United States, Washington | |
Pfizer Investigational Site | |
Seattle, Washington, United States, 89109 | |
Pfizer Investigational Site | |
Seattle, Washington, United States, 98195 | |
Germany | |
Pfizer Investigational Site | |
Grosshansdorf, Germany, 22927 | |
Pfizer Investigational Site | |
Mannheim, Germany, 68167 | |
Italy | |
Pfizer Investigational Site | |
Torino, Italy, 10126 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00321308 |
Other Study ID Numbers: |
A8501004 |
First Posted: | May 3, 2006 Key Record Dates |
Last Update Posted: | September 28, 2009 |
Last Verified: | September 2009 |
advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |