Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced 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 gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.

Detailed Description
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PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.

Official Title
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International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Gemcitabine
* Drug: PF-3512676
* Drug: Cisplatin
* Drug: Gemcitabine + Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 Exclusion Criteria: Small cell or carcinoid lung cancer Known Central Nervous System (CNS) metastasis Pre-existing auto-immune or antibody mediated diseases

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 |
| --- | --- |
| Experimental: A<br>Standard of Care chemotherapy plus experimental intervention (PF-3512676) | Drug: Cisplatin<br>* Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles<br>* Other names: Platinol-AQ;Drug: Gemcitabine<br>* Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles<br>* Other names: Gemzar;Drug: PF-3512676<br>* PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity<br>|
| Active Comparator: B<br>Standard of Care chemotherapy | Drug: Cisplatin<br>* Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles<br>* Other names: Platinol-AQ;Drug: Gemcitabine + Cisplatin<br>* Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 656 Events | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes |  | End of treatment | 
| Overall Safety Profile |  | 28 days post PF03512676 dosing | 
| Progression Free Survival |  | Time of primary endpoint | 
| Time to Tumor Progression |  | Time of progressive disease | 
| Overall Objective Response |  | End of treatment | 
| Duration of Response |  | Time of progressive disease | 

 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 III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator