A Phase 2A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Immune Response, Safety and Efficacy of HS-110 in Combination With Erlotinib vs. Erlotinib as a Single Agent in Patients With Advanced, Non-EGFR Mutated Non-Small Cell Lung Cancer (NSCLC)
This multicenter, randomized, double-blind, placebo-controlled study will enroll patients
with advanced NSCLC (squamous cell or non-squamous cell) without EGFR mutations (either
L858R or 746-750 deletions) who have had progression or recurrence of their disease
following at least one but no more than two prior regimens (adjuvant therapy excluded) of
approved therapy that did not include immunomodulating or anti-EGFR targeted therapy for
their disease. EFGR status must be known at the time of enrollment either via prior
determination or testing performed from archival tissue during the screening process.
Patients with resectable disease will eligible if resection can be deferred for the first
six weeks of vaccine. Patients will receive twice weekly dosing of vaccine (spatially
divided as 5 intradermal injections) for 18 weeks (36 total doses). Patients will be
randomized in a 2:1 fashion; with 30 patients in each of the HS110 treatments groups (high
and low dose) and 15 patients will receive placebo injections. Patients will also receive
erlotinib 150mg once daily for the duration of the trial. A total of 75 patients will be
enrolled in the trial. The study includes a lead-in phase of 9 patients (3 from each dosing
group) who will be observed weekly for 4 weeks to assess the safety of combining HS110 with
erlotinib. Treatment of the first 4 patients will be staggered by 2 week intervals to allow
for safety evaluation before treating additional patients. If the combination of proves to
be safe and well-tolerated in the first 9 patients, enrollment will be opened up to the
predetermined sample size for each arm. A Data Monitoring Committee (DMC) will be used in
this study to independently monitor adverse events and progression/survival data. The DMC
will meet at the completion of the run-in period and after half the patients have been dosed
through week 6 and week 12.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay)
Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.
Week 18
No
John Nemunaitis, MD
Principal Investigator
Mary Crowley Cancer Research Centers
United States: Food and Drug Administration
HS110-10-01
NCT01504542
December 2011
December 2012
Name | Location |
---|---|
Mary Crowley Cancer Research Centers | Dallas, Texas 75201 |