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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)

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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.

Inclusion Criteria:

- Willing and able to comply with the protocol and sign informed consent.

- Histologically or cytologically confirmed locally advanced or metastatic squamous
cell or non-squamous cell NSCLC after at least one but no more than two prior
regimens of approved therapy for their disease (not including adjuvant treatment).

- Confirmation that their disease has no known EGFR mutations based on documented prior
analysis or study-specific analysis of archival tumor tissue.

- At least one site of bi-dimensionally measurable NSCLC disease.

- Patients with recurrent, resectable disease able to undergo six weeks of vaccine
therapy prior to resection.

- Brain metastasis if present and treated must be stable by CT scn or MRI for at least
8 weeks.

- Age ≥ 18 years.

- EGOG performance status of 0-1.

- Lab parameters

- Albumin ≥ 3.5mg/dL

- Total Bilirubin < 1.5mg/dL

- Alanine transaminase (ALT), and aspartate transaminase(AST)≤ 2.5 x upper limits of
normal or ≤ x ULN in case of liver metastases.

- Serum creatinine < 1.5mg/dL or calculated creatinine clearance >50 mL/minute per the
Cockcroft-Gault formula.

- White blood cell (WBC) count ≥ 4,000/mm3 with an absolute neutrophil count

- 1,500mm3.

- Hemoglobin ≥ 9g/dL

- Platelet count ≥ 100,000/mm3

- Women of childbearing potential or men of fathering potential must use adequate birth
control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier
method with spermicide or surgical sterilization) during the study and for 6 months
after receiving the last administration of study medication. Female patients of
childbearing potential must test negative for pregnancy prior to enrolling in the
trial. Post-menopausal (cessation of menses for more than 6 months) women are
eligible for this study.

Exclusion Criteria:

- No prior therapy with EGFR-targeted drugs, including approved and investigational
therapies, or prior immunologic or biologic response modifier therapy for treatment
of their disease.

- Uncontrolled or untreated brain or spinal cord metastases or meningeal

- Known human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled
infections or intercurrent illness, unrelated to the tumor, requiring active therapy.

- Autoimmunity syndromes (primary or acquired) including, but not limited to, the
following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease,
sarcoidosis, vasculitis, polymyositis, or glomerulonephritis requiring active steroid
or other immunosuppressive therapy.

- Known immunodeficiency disorders, either primary or acquired.

- Other malignancies present within the past 3 years, except for cutaneous basal and/or
squamous cell carcinoma(s) or in situ cervical cancer.

- History of clinically significant cardiac impairment, congestive heart failure > New
York Heart Association (NYHA) cardiac disease classification Class II, unstable
angina, or myocardial infarction during the previous 6 months, or serious cardiac

- Known alcohol or chemical abuse, or mental or psychiatric condition precluding
compliance with the protocol.

- Chemotherapy, radiation, or other antitumor therapy during the last 4 weeks.

- Pregnant, nursing, or planning a pregnancy (both men and women) within 12 months of

- Known allergy to soy or egg products.

- Patient is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay)

Outcome Description:

Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.

Outcome Time Frame:

Week 18

Safety Issue:


Principal Investigator

John Nemunaitis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Cancer Research Centers


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Immunotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mary Crowley Cancer Research Centers Dallas, Texas  75201