Phase II Study of Erlotinib With or Without Hydroxychloroquine in Patients With Previously Untreated Advanced NSCLC and EGFR Mutations
- Because no one knows which of the study options are best, participants will be
randomized into of the study groups: Group A (erlotinib) or Group B (erlotinib and
HCQ). Study treatment will be divided into time periods called cycles. Each study
treatment cycle is 28 days.
- Erlotinib (Group A and Group B) will be taken orally once a day. Hydroxychloroquine
(Group B) will be taken orally once a day after taking erlotinib.
- The following tests and procedures will be performed day 1 of each cycle: physical
examination, performance status assessment, questions about any symptoms or side
effects, blood for routine tests. The following procedures will be performed at
certain study visits: Research blood tests (cycle 1, cycle 2, then every other even
cycle); eye exam (cycle 4, cycle 7, and then every 3 months); assessment of the tumor
with CT or MRI scan (done at the end of even cycles.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To demonstrate a difference in progression-free survival in patients with advanced NSCLC and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus HCQ.
2 years
No
Lecia Sequist, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
09-097
NCT00977470
October 2009
December 2014
Name | Location |
---|---|
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Maryland | Baltimore, Maryland 21201 |
Stanford Cancer Institute | Stanford, California 94305 |