Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

Phase 3

Terminated

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

• Registration Number: NCT00254904
• Lead Sponsor: Pfizer

Brief Summary

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

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.

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: 2008-06
• Study Completion: 2008-06
• 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: 839

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PF-3512676	Standard of Care chemotherapy plus experimental intervention (PF-3512676)
B	Gemcitabine + Cisplatin	Standard of Care chemotherapy
A	Cisplatin	Standard of Care chemotherapy plus experimental intervention (PF-3512676)
A	Gemcitabine	Standard of Care chemotherapy plus experimental intervention (PF-3512676)
B	Cisplatin	Standard of Care chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	656 Events

Secondary Outcome Measures

Name	Time	Method
Duration of Response	Time of progressive disease
Patient Reported Outcomes	End of treatment
Overall Safety Profile	28 days post PF03512676 dosing
Time to Tumor Progression	Time of progressive disease
Progression Free Survival	Time of primary endpoint
Overall Objective Response	End of treatment

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Wolverhampton, United Kingdom