Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen

Detailed Description
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PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.

Official Title
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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

Conditions
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Carcinoma, Non-Small Cell Lung

Intervention / Treatment
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* Drug: pemetrexed
* Drug: pemetrexed + PF-3512676


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>Standard of care chemotherapy | Drug: pemetrexed<br>* 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity<br>* Other names: Alimta;|
| Experimental: A<br>Standard of care chemotherapy plus experimental intervention (PF-3512676) | Drug: pemetrexed + PF-3512676<br>* pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 110 Events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Time of death | 
| Overall Safety Profile |  | 28 days post treatment | 
| Patient Reported Outcome |  | End of Treatment | 
| Time to Tumor Progression |  | End of treatment | 
| Overall Objective Response Rate |  | Time of disease progressive disease | 
| Duration of Response |  | Time of disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced carcinoma, non-small cell lung cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator