Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: PF-02341066; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965731

2009-012377-35 (EudraCT Number)

A8081002

Details and patient eligibility

About

This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
• evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
• tumors must have measurable disease as per RECIST

Exclusion criteria

• known interstitial lung disease
• prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Erlotinib

Active Comparator group

Treatment:

Drug: Erlotinib

Drug: Erlotinib

Erlotinib + PF-02341066

Experimental group

Treatment:

Drug: PF-02341066

Drug: Erlotinib

Drug: Erlotinib