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Lung NeoplasmPhase 3STOPNCT00676507

Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy

A Phase 3 study testing Lucanix™ in people with Lung Neoplasm and Carcinoma Non-small Cell Lung Cancer Stage IIIA, run by NovaRx Corporation at 82 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Lucanix™
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
532 participants
Where
82 sitesin 8 countries
Study dates
Jul 2008to Jan 2013
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
  • Stage IIIA (T3N2 only) or
  • Stage IIIB or
  • Stage IV.
  • Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
  • Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
Show all 19Show fewer
  • Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
  • Signed informed consent.
  • Not less than 18 years and not more than 75 years old.
  • Estimated life expectancy of at least 12 weeks.
  • Performance status (ECOG) ≤ 2.
  • Absolute neutrophil count ≥ 1,500/mm3.
  • Hemoglobin ≥ 9 g/dL.
  • Platelet count ≥ 100,000/mm3.
  • Albumin levels ≥ 2.5 g/dL.
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
  • Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
  • Creatinine ≤ 1.5 × ULN.
  • Alkaline phosphatase ≤ 5 × ULN.

Who cannot join

  • Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
  • Prior splenectomy.
  • Any surgery involving general anesthesia < 4 weeks prior to study registration.
  • Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
  • Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
  • Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
Show all 18Show fewer
  • Painful bone metastases, or bone metastases that require immediate therapy.
  • Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
  • Known allergies to eggs or soy.
  • Significant weight loss (≥ 10% body weight in preceding 6 weeks).
  • Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
  • Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
  • NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
  • Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
  • History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
  • Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  • Known active Epstein-Barr infection within ≤ 60 days of study registration.

Trial locations and contacts

82 sites in 8 countries.

82 sites in 8 countries

United States53 sites

  • Texas Cancer Center Abilene, Texas Oncology P.A.

    Abilene, Texas, 79606

  • Hematology Oncology Life Center

    Alexandria, Louisiana, 71301

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Allergy Partners of West North Carolina

    Asheville, North Carolina, 28801

  • Cancer Care of WNC

    Asheville, North Carolina, 28801

  • University of Colorado Health Science Center

    Aurora, Colorado, 80045

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • University of Tennessee Cancer Institute

    Bartlett, Tennessee, 38133

  • National Cancer Institute Center for Cancer Research, Medical Oncology Branch

    Bethesda, Maryland, 20892-1182

  • Pasco Hernando Oncology Associates, P.A.

    Brooksville, Florida, 34613

  • Gabrail Cancer Center Research LLC

    Canton, Ohio, 44718

  • Iowa Blood and Cancer Center

    Cedar Rapids, Iowa, 52402

  • Kootenai Cancer Center

    Coeur d'Alene, Idaho, 83814q

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Davis Memorial Cancer Care Center

    Elkins, West Virginia, 26241

  • University of Tennessee Cancer Institute

    Germantown, Tennessee, 38138

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29605

  • Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • St. Francis Medical Group Oncology and Hematology Specialists

    Indianapolis, Indiana, 46237

  • Clopton Clinic Hematology/Oncology

    Jonesboro, Arkansas, 72401

  • University of California, San Diego

    La Jolla, California, 92093

  • Medical Specialist of Palm Beaches

    Lake Worth, Florida, 33467

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • Allison Cancer Center, Texas Oncology, P.A.

    Midland, Texas, 79701

  • Optim Oncology

    Midwest City, Oklahoma, 73110

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Ocala Oncology

    Ocala, Florida, 34471

  • UCLA Pasadena Oncology

    Pasadena, California, 91105

  • Cancer Care Associates

    Redondo, California, 90277

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Atlanta Cancer Care

    Roswell, Georgia, 30076

  • Innovative Research Center of California

    San Diego, California, 92103

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Cancer Center

    Santa Monica, California, 90404

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona, 85259

  • Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr

    Seattle, Washington, 98109

  • University of Tennessee Cancer Institute

    Southaven, Mississippi, 38671

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Space Coast Medical Center

    Titusville, Florida, 32796

  • Tyler Cancer Center, Texas Oncology

    Tyler, Texas, 75702

  • UCLA Cancer Center-Valencia

    Valencia, California, 91355

  • UCLA Cancer Center

    Westlake Village, California, 91361

  • Marshfield Clinic Weston Center

    Weston, Wisconsin, 54476

Other trials in United States

Hungary7 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121

  • Semmelweis Egyetem Pulmonológiai Klinika

    Budapest, 1125

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1529

  • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza

    Deszk, 6772

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza

    Nyíregyháza, 4412

  • Fejér Megyei Szent György Kórház

    Székesfehérvár, 8000

  • Pest Megyei Tüdőgyógyintézet

    Törökbálint, 2045

Other trials in Hungary

Poland5 sites

  • Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku

    Gdansk, 80-952

  • Samodzielny Publiczny Szpital Kliniczny nr 4

    Lublin, 20-954

  • Wielkopolskie Centrum Pulmunologii i Torakochirurgii

    Poznan, 60-569

  • Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-784

  • Dolnoslaskie Centrum Chorob Pluc

    Wroclaw, 53-439

Other trials in Poland

India4 sites

  • Gujarat Cancer Hospital and Research Institute

    Ahmedabad, 380016

  • SEAROC Cancer Center, S.K.

    Jaipur, 302013

  • Tata Memorial Hospital

    Mumbai, 400012

  • Noble Hospital

    Pune

Other trials in India

Netherlands4 sites

  • Ziekenhuis Groep Twente - locatie Twenteborg Ziekenhuis

    Almelo, 7609 PP

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam

  • Universitair Medisch Centrum Maastricht

    Maastricht

Other trials in Netherlands

United Kingdom4 sites

  • Clatterbridge Centre for Oncology

    Bebington, Wirral, CH63 4JY

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Glasgow, G12 0YN

  • Guy's Hospital

    London, SE1 9RT

Other trials in United Kingdom

Serbia3 sites

  • Klinicko-bolnicki centar Bezanijska kosa

    Belgrade, 11000

  • Institute for pulmonary disease Sremska Kamenica

    Kamenitz, 21204

  • Klinicki Centar Nis

    Niš, 18000

Other trials in Serbia

Canada2 sites

  • University of Alberta Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy

Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer.

Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer.

Read the detailed description

Primary Efficacy Endpoints:

  • Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.

Secondary Efficacy Endpoints:

  • Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group.
  • Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the BSC control group.
  • Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the BSC control group.
  • Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the BSC control group.
  • Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC control group.
  • Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the BSC control group.
  • Adverse events of subjects treated with Lucanix™ will be compared to subjects in the control group.

Outline: This is a multicenter study. Subjects are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms.

  • Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix™) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
  • Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and some instances circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function.

Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year.

After completion of study treatment, subjects are followed every 3 months for 1 year and then annually for 4 years.

In two phase II trials, many subjects who received Lucanix™ at the same dose that will be administered in this trial had long-term disease stability with a good quality of life.

Being tested
Lucanix™, Placebo Comparator
Keywords
Gene therapy, Flow cytometry, Immunoenzyme technique, Laboratory biomarker analysis, Quality-of-life-assessment, Tumor cell-derivative vaccine therapy
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Lucanix™Biological

    Also called belagenpumatucel-L

    Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

  • Placebo ComparatorOther

    Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Study groups in NCT00676507
Study groupRoleWhat they receive
TreatmentExperimentalTreatment Arm: This course of therapy is Best Support Care (BSC) plus monthly intradermal (ID) injections of Lucanix™ (belagenpumatucel-L) consisting of 25,000,000 cells in a volume of 0.40 mL.
Receives: Biological: Lucanix™
Control ArmPlacebo comparatorControl Arm: This course of therapy is Best Support Care (BSC) plus a placebo injection that consists of 0.15% Intralipid® in solution composed of the cryopreservation formulation minus the gene modified cells and dimethyl sulfoxide (DMSO) in a volume of 0.40 mL.
Receives: Other: Placebo Comparator

What is being measured

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

  1. Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.

    Measured: 7 years

Secondary outcomes (7)

  1. Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group.

    Measured: 3 years

  2. Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Best Supportive Care control group.

    Measured: 3 years

  3. Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Best Supportive Care control group.

    Measured: 3 years

  4. Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group.

    Measured: 3 years

  5. Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group.

    Measured: 3 years

  6. Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the Best Supportive Care control group.

    Measured: 7 years

  7. Adverse events of subjects treated with Lucanix™ will be compared to subjects in the Best Supportive Care control group.

    Measured: 7 years

Timeline

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

  1. First posted13 May 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJan 2013
  4. Study completionJan 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676507
Sponsor's protocol ID
NR001-03
Other IDs
BB-IND 8868
Acronym
STOP
Status last verified
May 2015
First submitted
8 May 2008
Last updated
8 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Fakhrai H, Mantil JC, Liu L, Nicholson GL, Murphy-Satter CS, Ruppert J, Shawler DL. Phase I clinical trial of a TGF-beta antisense-modified tumor cell vaccine in patients with advanced glioma. Cancer Gene Ther. 2006 Dec;13(12):1052-60. doi: 10.1038/sj.cgt.7700975. Epub 2006 Jul 7.

    PubMed 16826191

  • Nemunaitis J, Nemunaitis M, Senzer N, Snitz P, Bedell C, Kumar P, Pappen B, Maples PB, Shawler D, Fakhrai H. Phase II trial of Belagenpumatucel-L, a TGF-beta2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients. Cancer Gene Ther. 2009 Aug;16(8):620-4. doi: 10.1038/cgt.2009.15. Epub 2009 Mar 13.

    PubMed 19287371

  • Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, Tong A, Kumar P, Pappen B, Hamilton C, DeVol E, Maples PB, Liu L, Chamberlin T, Shawler DL, Fakhrai H. Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer. J Clin Oncol. 2006 Oct 10;24(29):4721-30. doi: 10.1200/JCO.2005.05.5335. Epub 2006 Sep 11.

    PubMed 16966690

  • Giaccone G, Bazhenova LA, Nemunaitis J, Tan M, Juhasz E, Ramlau R, van den Heuvel MM, Lal R, Kloecker GH, Eaton KD, Chu Q, Dunlop DJ, Jain M, Garon EB, Davis CS, Carrier E, Moses SC, Shawler DL, Fakhrai H. A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer. Eur J Cancer. 2015 Nov;51(16):2321-9. doi: 10.1016/j.ejca.2015.07.035. Epub 2015 Aug 14.

    PubMed 26283035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lucanix™ in people with Lung Neoplasm and Carcinoma Non-small Cell Lung Cancer Stage IIIA, run by NovaRx Corporation at 82 sites in 8 countries.

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 19 inclusion and 18 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: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Hungary, Poland, India, Netherlands and 3 more countries. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. (time frame: 7 years). 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 NCT00676507, which also lists 4 linked publications.

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 8 May 2015.

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