An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Pfizer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Docetaxel; Drug: Pemetrexed; Drug: PF-02341066

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932893

2009-012595-27 (EudraCT Number)

A8081007

Details and patient eligibility

About

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically or cytologically proven diagnosis of non-small cell lung cancer
• positive for the ALK fusion gene (test provided by a central laboratory)
• must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
• tumors must be measurable

Exclusion criteria

• prior treatment with PF-02341066
• current treatment in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

347 participants in 2 patient groups

PF-02341066

Experimental group

Treatment:

Drug: PF-02341066

Pemetrexed or Docetaxel

Active Comparator group

Description:

Investigator selection of either pemetrexed or docetaxel as the active comparator

Treatment:

Drug: Pemetrexed

Drug: Docetaxel