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Non-small Cell Lung CancerPhase 2/3NCT01774578

Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer

A Phase 2/3 study testing Docetaxel, HyperAcute®-Lung Immunotherapy and Gemcitabine in people with Non-small Cell Lung Cancer and Progression of Non-small Cell Lung Cancer, run by NewLink Genetics Corporation at 24 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, HyperAcute®-Lung Immunotherapy and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
24 sitesUnited States
Study dates
Feb 2013to 18 Jun 2016
Phase
Phase 2/3
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

  • Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma, and large cell anaplastic lung carcinoma histologies are eligible as are mixed histologies of NSCLC (i.e., adenosquamous). Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are not eligible.
  • Stage IIIB (AJCC Stage IIIB - Any T,N3M0 or T4N2M0) or Metastatic (AJCC Stage IV- any T, any N, M1), progressive, recurrent or refractory NSCLC. Patients may not be eligible for other curative intent treatment (e.g., surgical resection).
  • For the purpose of eligibility for this trial, the above-cited disease states are defined as follows:
  • Progressive NSCLC: Defined as increasing measurable disease, or the appearance of new measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria despite treatment.
  • Recurrent NSCLC: Defined as the re-appearance of measurable disease, or the appearance of new measurable disease by RECIST Criteria after prior successful treatment or complete response.
  • Refractory NSCLC: Defined as achieving less than a complete response and having residual measurable disease by RECIST criteria after prior treatment with chemotherapy, targeted or small molecules, monoclonal antibodies or any combination of these.
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  • Eastern Cooperative Oncology Group (ECOG)Performance Status ≤ 1.
  • Serum albumin ≥3.0 gm/dL.
  • Expected survival ≥4 months.
  • Adequate organ function including:
  • Marrow: Hemoglobin ≥10.0 dm/dL, absolute granulocyte count (AGC)≥1,000/mm^3, platelets ≥100,000/mm^3, absolute lymphocyte count ≥1000/mm^3.
  • Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT) ≤2.5 x ULN.
  • Renal: Serum creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥50 mL/min.
  • Measurable disease as defined by RECIST Criteria.
  • Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy and/or ≤ 2 prior chemotherapy regimens (such as neoadjuvant/adjuvant treatment), however only 1 chemotherapy regimen in the metastatic setting is allowed.
  • Treatment with a single course of gefitinib(Iressa®) or erlotinib (Tarceva®), or other small molecule or targeted therapies, or monoclonal antibody therapy (excluding docetaxel) will be considered and count as prior chemotherapy.
  • Patients receiving preoperative (Neoadjuvant) and postoperative adjuvant chemotherapy (within 12 weeks of surgery) with the same agent(s) will be considered to have received a single chemotherapy regimen.
  • Patients must be ≥ 4 weeks since major surgery, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) or biotherapy/target therapies and ≥ 2 weeks since radiotherapy.
  • Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
  • Male and female subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental drug and for one month after the last immunization.

Who cannot join

  • Age < 18-years-old.
  • Active central nervous system (CNS) disease, metastases or carcinomatous meningitis. Patients with CNS metastases must be at least 2 weeks status post prior therapy to the brain and be off all steroids without progressing CNS disease.
  • Hypercalcemia >2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin and/or bisphosphate therapy).
  • Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
  • Other malignancy within three years, unless the probability of recurrence is <5%. Patients curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
  • History of organ transplant, or current active immunosuppressive therapy (such as cyclosporine, tacrolimus, etc.).
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  • Subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Decadron treatment with docetaxel is acceptable.
  • Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
  • Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp > 38.1°C) if deemed clinically significant by the treating physician.
  • Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
  • Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).
  • Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
  • A known allergy to any component of the HyperAcute®-Lung immunotherapy or cell lines from which it is derived.
  • Patients having undergone splenectomy.
  • Known HIV positive.
  • Subjects who received any prior treatment with docetaxel are excluded. Subjects who have received gemcitabine in first line therapy but do not have squamous cell carcinoma, will be eligible as they can receive pemetrexed for the salvage regimen.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Deaconess Clinic

    Evansville, Indiana, 47713

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • University of Florida

    Gainesville, Florida, 32610

  • Indiana University Health Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Vince Lombardi Cancer Clinic

    Green Bay, Wisconsin, 54311

  • Indiana University

    Indianapolis, Indiana, 46202

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Lynchburg Hematology Oncology Clinic

    Lynchburg, Virginia, 24501

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • North Mississippi Hematology and Oncology Associates at BridgePoint

    Tupelo, Mississippi, 38801

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Open-label, Randomized Phase IIB/III Active Control Study of Second-line Tergenpumatucel-L (Hyper-Acute(R)-Lung ) Immunotherapy Versus Docetaxel in Progressive or Relapsed Non-Small Cell Lung Cancer

The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.

Read the detailed description

Non-small cell lung cancer (NSCLC) remains the leading cause of cancer death in men and women in the United States. Despite advances in the treatment of advanced NSCLC in the last decade, survival outcomes remain poor. Treatment benefit from cytotoxic chemotherapy has reached a plateau and further progress will depend upon identifying novel methods to target tumor cells.

Harnessing the human immune system to target lung cancer could result in the development of effective treatment options against lung cancer and potentially enhance the effect of cytotoxic chemotherapy. Lung cancer cells produce a number of abnormal proteins or abnormal amounts of certain proteins found in normal lung cells. In some cancers, the abnormal protein expression may lead to an immune response against the cancer cells much in the way the immune system responds to an infection. In progressive lung cancer however, the immune system fails to identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a novel method to stimulate the immune system to recognize the abnormal components found in lung cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer.

This new method of treatment helps the immune system of lung cancer patients to "identify" and target the cancerous tissue. As an example, patients who receive an organ transplant to replace a damaged kidney or heart are treated with special drugs to supress their immune response from destroying or "rejecting" the transplanted organ. This "rejection" occurs when the patient's immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, perhaps like differences between organs from pigs and the immune system cells of humans, the rejection is very rapid, highly destructive and the immunity it generates is long-lasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their lung cancer just as the body would learn to reject a transplanted organ from an animal.

To do this, we have placed a mouse gene into cultured human lung cancer cell lines. These cells will express a sugar that will stimulate a strong immune response in humans. These cancer cells are irradiated to prevent any growth and then injected along with chemotherapy to patients with lung cancer. The presence of the sugar will stimulate the patient's immune system to kill the injected immunotherapy cells. As part of the process of destroying the immunotherapy cells, the patient's immune system is stimulated to identify as many differences between these cancer cells and normal human cells. This extra stimulation is thought to encourage immune responses against the lung cancer in the patient based on shared abnormalities of lung cancer immunotherapy cells and the patient's lung cancer cells.

In this experimental therapy, patients are given docetaxel or injections of an immunotherapy consisting of three types of modified lung cancer cells. We propose to test these treatments in patients with lung cancer who have progressed after initial chemotherapy to demonstrate that treatment of immunotherapy results in improved tumor stabilization or response and could potentially improve the patient's overall survival.

Being tested
Docetaxel, HyperAcute®-Lung Immunotherapy, Gemcitabine, Pemetrexed
Keywords
Non-small Cell Lung Cancer, Vaccine Therapy, Immunotherapy, Second line therapy, Progressive, Relapsed
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Recurrence

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere®

    Docetaxel given in Arm 1 prior to first progression on study. Given as an option of salvage therapy after first progression on study for Arms 2a and 2b.

  • HyperAcute®-Lung ImmunotherapyBiological

    Also called Tergenpumatucel-L

    HAL-1, HAL-2 and HAL-3 immunotherapy components.

    Up to 16 immunizations of 300 million immunotherapy cells.

  • GemcitabineDrug

    Also called Gemzar®

    Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.

  • PemetrexedDrug

    Also called Alimta®

    Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.

Study groups in NCT01774578
Study groupRoleWhat they receive
Arm 1: DocetaxelActive comparatorArm 1: Docetaxel 75 mg/m^2 IV given every 3 weeks x 4 doses. If response or stable: Observe until disease progression. First Progression: Gemcitabine 1250 mg/m^2/week for 2 weeks with 1 week rest or Pemetrexed 500 mg/m^2 every 3 weeks until disease progression or significant toxicity.
Receives: Drug: Docetaxel; Drug: Gemcitabine; Drug: Pemetrexed
Arm 2a: HyperAcute®-Lung Immunotherapy (weekly)ExperimentalArm 2a: 300 Million HAL cells given by intradermal injection weekly for 11 weeks and then every 2 months for 5 additional doses. Up to 16 total immunizations of 300 million immunotherapy cells until disease progression or toxicity. First Progression: Docetaxel 75 mg/m^2 IV given every 3 weeks or Gemcitabine 1250 mg/m^2 for 2 weeks with 1 week rest or Pemetrexed 500 mg/m^2 every 3 weeks until disease progression or significant toxicity and continue with HAL administration given every 2 weeks (not to exceed 16 total immunizations).
Receives: Drug: Docetaxel; Biological: HyperAcute®-Lung Immunotherapy; Drug: Gemcitabine; Drug: Pemetrexed
Arm 2b: HyperAcute®-Lung Immunotherapy (biweekly)ExperimentalArm 2b: 300 Million HAL cells given by intradermal injection biweekly for 6 doses and then every month for 10 additional doses. Up to 16 total immunizations of 300 million immunotherapy cells until disease progression or toxicity. First Progression: Docetaxel 75 mg/m^2 IV given every 3 weeks or Gemcitabine 1250 mg/m^2 for 2 weeks with 1 week rest or Pemetrexed 500 mg/m^2 every 3 weeks until disease progression or significant toxicity and continue with HAL administration given every 2 weeks (not to exceed 16 total immunizations).
Receives: Drug: Docetaxel; Biological: HyperAcute®-Lung Immunotherapy; Drug: Gemcitabine; Drug: Pemetrexed

What is being measured

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

  1. Overall survival

    The primary objective in Phase IIB and Phase III is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung (HAL) Immunotherapy versus docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.

    Measured: Approximately 19 months, assuming a 24 month enrollment.

Secondary outcomes (3)

  1. Dosing schedule

    A secondary objective in Phase IIB is to determine the response rates of HyperAcute®-Lung (HAL) Immunotherapy given in a weekly and biweekly regimen versus docetaxel.

    Measured: Approximately 19 months, assuming a 24 month enrollment.

  2. Tumor response rate

    A secondary outcome measure in Phase IIB and Phase III is to measure tumor response including response to follow-on salvage regimens to assess chemosensitization effects.

    Measured: Approximately 19 months, assuming a 24 month enrollment.

  3. Immunologic Response

    A secondary outcome measure in Phase IIB and Phase III is to assess the immunological response of patients with lung cancer treated with HyperAcute®-Lung (HAL) Immunotherapy versus docetaxel in patients with progressed or relapsed NSCLC that have been previously treated.

    Measured: Approximately 19 months, assuming a 24 month enrollment.

Timeline

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

  1. First posted24 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completion18 May 2016
  4. Study completion18 Jun 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774578
Sponsor's protocol ID
NLG0301
Other IDs
1209-1184
Status last verified
May 2020
First submitted
7 Jan 2013
Last updated
28 May 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Docetaxel, HyperAcute®-Lung Immunotherapy and Gemcitabine in people with Non-small Cell Lung Cancer and Progression of Non-small Cell Lung Cancer, run by NewLink Genetics Corporation at 24 sites 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 20 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 stopped early. Results are not available in the source record.

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?

Overall survival (time frame: Approximately 19 months, assuming a 24 month enrollment.). 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 NCT01774578.

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 28 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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