Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-small Cell

Treatments: Drug: Dacomitinib (PF-00299804)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818441

A7471017

2011-002794-39 (EudraCT Number)

Details and patient eligibility

About

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced adenocarcinoma of lung, measurable disease
• Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
• patients with known EGFR activating mutation regardless of smoking status
• ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion criteria

• Active brain metastases
• Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
• known EGFR wild type NSCLC

Trial design

119 participants in 2 patient groups

Cohort A

Experimental group

Description:

Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC

Treatment:

Drug: Dacomitinib (PF-00299804)

Drug: Dacomitinib (PF-00299804)

Cohort B

Experimental group

Description:

Dacomitinib in patients with HER2 mutated or amplified NSCLC

Treatment:

Drug: Dacomitinib (PF-00299804)

Drug: Dacomitinib (PF-00299804)