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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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Lung Neoplasm, Carcinoma Non-small Cell Lung Cancer Stage IIIA, Carcinoma Non-small Cell Lung Cancer Stage IIIB, Carcinoma Non-small Cell Lung Cancer Stage IV

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Trial Information

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


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.


Inclusion Criteria:



- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

7 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

NR001-03

NCT ID:

NCT00676507

Start Date:

July 2008

Completion Date:

October 2012

Related Keywords:

  • Lung Neoplasm
  • Carcinoma Non-small Cell Lung Cancer Stage IIIA
  • Carcinoma Non-small Cell Lung Cancer Stage IIIB
  • Carcinoma Non-small Cell Lung Cancer Stage IV
  • Gene therapy
  • Flow cytometry
  • Immunoenzyme technique
  • Laboratory biomarker analysis
  • Quality-of-life-assessment
  • Tumor cell-derivative vaccine therapy
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
James Graham Brown Cancer CenterLouisville, Kentucky  40202
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Alaska Regional HospitalAnchorage, Alaska  99508
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Atlanta Cancer CareAtlanta, Georgia  30342
Henry Ford Health SystemDetroit, Michigan  48202
University of Colorado Health Science CenterAurora, Colorado  80010-0510
Ocala OncologyOcala, Florida  34474
University of California, San DiegoLa Jolla, California  92037-1709
Cancer Care AssociatesFresno, California  93720
Santa Barbara Hematology Oncology Medical Group, Inc.Santa Barbara, California  93105
Eastchester Center for Cancer CareBronx, New York  10469
Cancer Center of the CarolinasGreenville, South Carolina  29615
Hematology Oncology Life CenterAlexandria, Louisiana  71301
Cancer Care of WNCAsheville, North Carolina  28801
Marshfield Clinic Weston CenterWeston, Wisconsin  54476
Central Coast Medical Oncology CorporationSanta Maria, California  93454
University of Minnesota Medical CenterMinneapolis, Minnesota  55455
Kootenai Cancer CenterPost Falls, Idaho  83854
Richmond University Medical CenterStaten Island, New York  10310-1699
Pasco Hernando Oncology Associates, P.A.14529 Cortez Blvd., Florida  34613
Southern Cancer CenterMobile, Alabama  36608
Mary Crowley Cancer Research CentersDallas, Texas  75201
Sansum ClinicSanta Barbara, California  93105
University of Tennessee Cancer InstituteSouthaven, Mississippi  38671
Mayo Clinic Cancer CenterScottsdale, Arizona  85259
Clopton Clinic Hematology/OncologyJonesboro, Arkansas  72401
UCLA Pasadena OncologyPasadena, California  91105
Innovative Research Center of CaliforniaSan Diego, California  92103
UCLA Cancer CenterSanta Monica, California  90404
UCLA Cancer Center-ValenciaValencia, California  91355
Medical Specialist of Palm BeachesLake Worth, Florida  33467
Space Coast Medical CenterTitusville, Florida  32796
St. Francis Medical Group Oncology and Hematology SpecialistsIndianapolis, Indiana  46237
Iowa Blood and Cancer CenterCedar Rapids, Iowa  52402
National Cancer Institute Center for Cancer Research, Medical Oncology BranchBethesda, Maryland  20892-1182
Allergy Partners of West North CarolinaAsheville, North Carolina  28801
Gabrail Cancer Center Research LLCCanton, Ohio  44718
Optim OncologyMidwest City, Oklahoma  73110
Texas Cancer Center Abilene, Texas Oncology P.A.Abilene, Texas  79606
Allison Cancer Center, Texas Oncology, P.A.Midland, Texas  79701
Tyler Cancer Center, Texas OncologyTyler, Texas  75702
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med CtrSeattle, Washington  98109
Davis Memorial Cancer Care CenterElkins, West Virginia  26241