A Phase I/II Study of PF-06463922 in Patients with Non-Small Cell Lung Cancers with ALK or ROS1 Mutations

Full Title

Phase 1/2 Study of PF-06463922 (an ALK/ROS1 Tyrosine Kinase Inhibitor) in Patients with Advanced Non-Small Cell Lung Cancer Harboring Specific Molecular Alterations

Purpose

ALK and ROS1 are gene fusions that promote the growth of some lung cancers. PF-06463922 is an investigational drug designed to inhibit the enzyme produced by these genetic mutations, interfering with lung cancer growth.

In this study, researchers are studying the safety and effectiveness of PF-06463922 in patients with advanced non-small cell lung cancers (NSCLC) that contain mutations in the ALK or ROS1 genes. PF-06463922 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced or metastatic NSCLC that contains a mutation in the ALK or ROS1 gene.
  • Patients' cancers must either have not yet been treated, or continued to grow despite prior therapies that target ALK or ROS1 tyrosine kinases (the enzymes produced by the mutated genes).
  • For the phase I portion of the study, patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • For the phase II portion of the study, patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.

Protocol

15-132

Phase

I/II

Investigator

Co-Investigators

Locations