Full TitleA Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered with Erlotinib or Alectinib in Patients with Advanced Non-Small Cell Lung Cancer
Most non-small cell lung cancers (NSCLC) treated with the standard therapy erlotinib (a drug used to treat cancers with a mutated form of the epidermal growth factor receptor, or EGFR) eventually come back or continue to grow despite this treatment. Researchers want to find out if adding the investigational drug MPDL3280A to erlotinib therapy might make treatment more effective.
They also want to see if MPDL3280A can be given safely with the investigational drug alectinib in patients with advanced NSCLC who have alterations in a gene called ALK, which is responsible for the production of an overactive protein that fuels NSCLC growth. Alectinib is approved in Japan for patients with NSCLC that contains ALK mutations; its use in the United States is investigational.
The investigators have completed enrollment for the part of the study assessing the combination of MPDL3280A and erlotinib. The study is now focusing on patients with ALK-mutant lung cancer. Researchers are finding the highest dose of MPDL3280A that can be given safely together with the standard dose of erlotinib in patients with advanced NSCLC that has not previously been treated with erlotinib or other EGFR inhibitors, or together with alectinib in patients with ALK-mutant NSCLC. They are also assessing patients’ responses to these drug combinations.
MPDL3280A is designed to improve the immune system¿s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. MPDL3280A is given intravenously (by vein), while erlotinib and alectinib are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage IIIB, stage IV, or recurrent NSCLC.
- Patients receiving erlotinib must have cancers that contain mutated EGFR, and they may not have previously received erlotinib or any other EGFR inhibitors.
- Patients receiving alectinib must have NSCLC that contains an ALK gene alteration.
- At least 3 weeks must pass between completion of other therapies and entry into 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.
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Charles Rudin at 646-888-4527.