Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

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 paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

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/survival follow-up. Data collection was completed on 22 May 2008.

Official Title
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A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: paclitaxel + carboplatin + bevacizumab
* Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer ECOG Performance Status 0-1 Measurable disease per RECIST criteria Exclusion Criteria: Squamous cell, small cell, or carcinoid lung cancer CNS metastasis Pre-existing autoimmune or antibody mediated disease Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs

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: paclitaxel + carboplatin + bevacizumab<br>* paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles<br>* Other names: Taxol; Paraplatin;|
| Experimental: A<br>Standard of care chemotherapy plus experimental intervention (PF-3512676) | Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676<br>* carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles<br>* Other names: Paraplatin; Taxol; Avastin;|

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 |
| --- | --- | --- |
| Time to Tumor Progression |  | End of treatment | 
| Overall Objective Response Rate |  | Time of progressive disease | 
| Duration of Response |  | Time of progression | 
| Overall Survival |  | Time of death | 
| Overall safety profile |  | 28 days post treatment | 

 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, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator