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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: PF-3512676; Drug: Gemcitabine + Cisplatin; Drug: Gemcitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254904

A8501002

Details and patient eligibility

About

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.

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 (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.

Enrollment: 839 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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839 participants in 2 patient groups

A

Experimental group

Description:

Standard of Care chemotherapy plus experimental intervention (PF-3512676)

Treatment:

Drug: PF-3512676

Drug: Cisplatin

Drug: Gemcitabine

Drug: Cisplatin

B

Active Comparator group

Description:

Standard of Care chemotherapy

Treatment:

Drug: Cisplatin

Drug: Gemcitabine + Cisplatin

Drug: Cisplatin