Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

This study will enroll patients with locally advanced or metastatic non-EGFR mutated Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than two prior approved treatment regimens. Patients will be randomized to receive one of two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and patients will also receive erlotinib 150mg taken orally once daily for the duration of the trial. The study will examine the immune effects, safety and efficacy of two different doses of HS110 vaccine in combination with erlotinib versus erlotinib alone.

Key facts

Study ID

NCT01504542

Run by

Heat Biologics

People needed

0

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2013-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 carcinomatosis.
• 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 arrhythmia.
• 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 enrollment.
• Known allergy to soy or egg products.
• Patient is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Where it is running

• Mary Crowley Cancer Research Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.