Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Erlotinib; Drug: PF-3512676 + Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321815

A8501006

Details and patient eligibility

About

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced, EGFR-positive NSCLC
• ECOG Performance Status 0, 1 or 2
• Measurable disease

Exclusion criteria

• Known CNS metastasis
• Pre-existing autoimmune or antibody mediated disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: PF-3512676 + Erlotinib

B

Active Comparator group

Description:

Standard of Care chemotherapy

Treatment:

Drug: Erlotinib