Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin 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 paclitaxel

Detailed Description
-----------------
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 (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

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

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: PF-3512676 + Paclitaxel + Carboplatin
* Drug: Paclitaxel + Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 experiment intervention (PF-3512676) | Drug: PF-3512676 + Paclitaxel + Carboplatin<br>* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.<br>* Other names: Taxol; Paraplatin;|
| Active Comparator: B<br>Standard of care chemotherapy | Drug: Paclitaxel + Carboplatin<br>* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.<br>* Other names: Taxol; Paraplatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Objective Response |  | End of Treatment | 
| Time to Tumor Progression |  | Time of progressive disease | 
| Progression Free Survival |  | Time of primary endpoint | 
| Duration of Response |  | Time of progressive disease | 
| Patient Reported Outcomes |  | End of Treatment | 
| Overall Safety Profile |  | 28 days post PF-3512676 dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator