A clinical trial to study the effects of Lucanix (Test Drug) in patients suffering from advanced non small cell Lung Cancer who have previously responded to or have a stable disease following treatment with platinum based combination chemotherapy.

Phase 3

Conditions: Non-Small Cell Lung Cancer

Registration Number: CTRI/2010/091/000486

Lead Sponsor: NovaRx Corporation

Brief Summary: 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-Î³ 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. The study treatment period is for 2 years, followed by follow up of 5 years. It is expected that around 70 patients will be enrolled from India. The first patient was enrolled for the study in India on 13-Apr-2009

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 700

Inclusion Criteria

oSubjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements: Stage IIIA (T3N2 only) or Stage IIIB or Stage IV.
oSubjects must have stable disease (SD) or better following 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.
oNot 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.
oSubjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
Signed informed consent.
oNot less than 18 years and not more than 75 years old.
oEstimated life expectancy of at least 12 weeks.
oPerformance status (ECOG) ≤ 2.
oAbsolute neutrophil count ≥ 1,500/mm3.
oHemoglobin ≥ 9 g/dL.
oPlatelet count ≥ 100,000/mm3.
oAlbumin levels ≥ 2.5 g/dL.
oBilirubin ≤ 1.5 times the upper limit of normal (ULN).
oAspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 Ã— ULN.
oCreatinine ≤ 1.5 Ã— ULN.
oAlkaline phosphatase ≤ 5 Ã— ULN.

Exclusion Criteria

oConcurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).oPrior splenectomy.oAny surgery involving general anesthesia < 4 weeks prior to study registration.oChemotherapy more than 4 months or less than 4 weeks prior to study registration.oSteroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, other investigational products or immunotherapy less than 4 weeks prior to study registration.oSubjects 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.oPainful bone metastases, or bone metastases that require immediate therapy.oSignificant 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.oKnown allergies to eggs or soy.oSignificant weight loss (≥ 10% body weight in preceding 6 weeks).oKnown HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).oSerious 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.oNCI CTC Grade 3 or 4 peripheral neuropathy at study registration.oPrior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.oHistory of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.oPregnant 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.oKnown active Epstein-Barr infection within ≤ 60 days of study registration.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix?) vs placebo.	The primary analysis time point for all outcome variables will be the time of the primary analysis \| for overall survival.

Secondary Outcome Measures

Name	Time	Method
Evaluate the progression free survival (PFS) of subjects treated with Lucanix compared to treatment within the Best Support Care (BSC)control group.	PFS and TTP will be analyzed using the same methods as described for the primary endpoint.PFS will be calculated from the date of randomization to the date of documented tumor

Trial Locations

Locations (6): Apollo Hospitals
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Gujarat Cancer Hospital and Research Institute,
🇮🇳
Ahmadabad, GUJARAT, India
Noble Hospital
🇮🇳
Pune, MAHARASHTRA, India
Regional Cancer Center
🇮🇳
India
SEAROC Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Apollo Hospitals
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr. Srinivas Chakravarthy Gummaraju
Principal investigator
9989299091
hydaherf@gmail.com