Clinical Trials:
NovaRx has reached an agreement with the FDA on the basic design of the Lucanix Phase III trial. Fast-Track Status and Special Protocol Assessment (SPA) approval for the trial has been granted. The trial can be viewed on the NIH clinical trials website at http://www.clinicaltrial.gov/ct2/show/NCT00676507?term+Lucanix&rank+1
The title of the study is:
Registration 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 Patients Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy.
The trial will be a pivotal, registration study of Lucanix as maintenance therapy for stages III/IV NSCLC patients who have responded to or have stable disease following one regimen of front-line platinum-based combination chemotherapy. It will be an international, multicenter, randomized, double-blinded, placebo-controlled study. Patients will receive best supportive care with monthly injections with 2.5 × 107 cells in the Lucanix treatment arm or best supportive care with a placebo injection in the control arm. The adaptive trial design allows NovaRx to enroll up to 700 patients if necessary to achieve statistical significance.
The trial will evaluate the ability of Lucanix to significantly prolong the median progression-free survival (PFS) or overall survival of patients when compared to best supportive care. The trial will also evaluate other endpoints including quality of life, time-to-progression, tumor response, response duration, the development of brain metastases, and overall safety.
The principle inclusion criteria for the protocol are:
- Patients with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
- Stage IIIA (T3N2 only) or
- Stage IIIB or
- Stage IV.
- Patients 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. Combination chemotherapy consists of a platinum-based chemotherapy drug either alone or in combination with other drugs, as practiced by the clinical site. Documentation of SD or objective responses shall be determined by comparison of a scan, performed 1 to 4 months prior to signing the informed consent document, with the scan performed at baseline.
- Not less than one month and no more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
- Not less than 18 years and not more than 75 years old.
- Performance status (ECOG) 2.
- Estimated life expectancy of at least 12 weeks.
The principle exclusion criteria for the protocol are:
- 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 < 4 weeks prior to study registration.
- Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy < 4 weeks prior to study registration.
- Objective evidence of brain metastases.
- Significant and/or symptomatic pleural effusions.
- Known allergies to eggs or soy.
- 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.
Given the innovative nature of the therapy and the adaptive Lucanix Phase III design, many influential oncologists worldwide have signed-on to participate in the trial. Internally, NovaRx has recruited a plethora of the strongest global clinical sites including the NCI/NIH, Mayo Clinic, and multifarious other cancer centers of high prestige in the US, Canada, and possibly the UK, Germany, Poland, the Netherlands, Hungary, India, Serbia/Montenegro, and Italy.
Glionix (Glioma vaccine) trial design is underway and the trial is anticipated to commence in late 2008.
