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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Paclitaxel + Carboplatin; Drug: PF-3512676 + Paclitaxel + Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254891

A8501001

Details and patient eligibility

About

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

Full 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.

Enrollment: 828 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

828 participants in 2 patient groups

A

Experimental group

Description:

Standard of care chemotherapy plus experiment intervention (PF-3512676)

Treatment:

Drug: PF-3512676 + Paclitaxel + Carboplatin

B

Active Comparator group

Description:

Standard of care chemotherapy

Treatment:

Drug: Paclitaxel + Carboplatin