A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Dacomitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858389

A7471047

Details and patient eligibility

About

This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
• Evidence of T790M mutation to enroll in Cohort A.
• Evidence of measurable disease by radiographic technique.
• Adequate organ function.

Exclusion criteria

• Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression.
• Symptomatic brain metastases.
• Uncontrolled or significant cardiovascular disease.
• Pregnant or breastfeeding.

Trial design

41 participants in 2 patient groups

Cohort A

Experimental group

Description:

Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.

Treatment:

Drug: Dacomitinib

Drug: Dacomitinib

Cohort B

Experimental group

Description:

Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.

Treatment:

Drug: Dacomitinib

Drug: Dacomitinib