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Non-small Cell Lung CancerPhase 2NCT01504542

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

A Phase 2 study testing HS110 vaccine in people with Non-small Cell Lung Cancer, run by Heat Biologics at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
HS110 vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2011to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75201

Other trials in United States

About this study

Official title: 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 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.

Read the detailed description

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.

Being tested
HS110 vaccine, Placebo
Keywords
Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS110 vaccineBiological

    0.5ml to be administered twice weekly for 18 weeks (36 doses)

  • PlaceboBiological

    0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)

  • HS110 vaccineBiological

    0.5 mls to be dosed twice weekly for 18 weeks (36 doses)

Study groups in NCT01504542
Study groupRoleWhat they receive
Low-dose HS-110Experimental2,000,000 cells/0.5mls + erlotinib 150mg orally once daily
Receives: Biological: HS110 vaccine
High dose HS110Experimental10,000,000 HS110 cells/0.5ml + erlotinib 150mg orally once daily.
Receives: Biological: HS110 vaccine
Placebo vaccine + erlotinib 150mg orally once dailyPlacebo comparatorPlacebo vaccine buffered saline solution + erlotinib 150mg orally once daily
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 18

Secondary outcomes (5)

  1. Safety of the combination of HS110 vaccine and erlotinib

    Incidence and severity of adverse events, changes in laboratory measures, physical exams and evaluation of autoimmune phenomena.

    Measured: Up to 1 year

  2. Tumor assessment by immunologic response criteria (irRC)

    Patients will have a CT scan performed at baseline, Week 12 and Week 22 or at the end of study visit in the case of early termination from study. Investigators will assess the disease response using irRC for overall response, CR, PR, SD or PD.

    Measured: Baseline, Week 12 and Week 22

  3. Exploratory Immunologic endpoint - evaluation of circulating tumor cells

    Analysis via a semiautomated, epithelial cell adhesion molecule-based immunomagnetic technique.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

  4. Exploratory immunologic endpoint - immune function

    Analysis of cell surfance molecules by flow cytometry

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

  5. Exploratory immunologic endpoint - proteomic profile

    Examination of protein expression utilizing western blot, immunohistochemical staining, enzyme linked immunosorbent assay (ELISA) or mass spectrometry

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504542
Sponsor's protocol ID
HS110-10-01
Status last verified
Nov 2013
First submitted
20 Dec 2011
Last updated
21 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS110 vaccine in people with Non-small Cell Lung Cancer, run by Heat Biologics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay) (time frame: Week 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504542.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.

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