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

Phase 3

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Paclitaxel + Carboplatin; Drug: PF-3512676 + Paclitaxel + Carboplatin

• Registration Number: NCT00254891
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 828

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Paclitaxel + Carboplatin	Standard of care chemotherapy
A	PF-3512676 + Paclitaxel + Carboplatin	Standard of care chemotherapy plus experiment intervention (PF-3512676)

Primary Outcome Measures

Name	Time	Method
Overall Survival	656 Events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Swansea, United Kingdom