Lung Cancer – NCI-08-C-0083
Dr. Giuseppe Giaccone
Principal Investigator
NCI is currently conducting the following trial for patients with lung cancer. Click on the trial below for additional details, including a summary of eligibility criteria, treatment plan, and information on how to contact Dr. Giaccone and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
This is a multicenter study. Patients 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). Patients are randomized to one of two treatment arms.
- Arm I:
- Patients 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
- Patients 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
Arm II:
- Blood samples are collected periodically and analyzed for cytokines and chemokines and 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
- Patients 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, patients are followed every 3 months for 1 year and then annually for 4 years
Why is this trial important?
Currently, we are limited in the treatment options for patients with advanced non-small cell lung cancer (NSCLC). The use of standard chemotherapy using a platinum agent in addition to another approved cytotoxic chemotherapy agent has resulted in only small improvements in overall survival of patients with lung cancer. Patients with recurrent and progressive disease after initial treatment have few treatment options and treatment only offers a minimally improvement in overall survival. There are currently no approved treatments after patients have received initial chemotherapy for advanced lung cancer. This study is a placebo-controlled trial to determine if using the vaccine Lucanix™ (Belagenpumatucel-L) will prolong survival in advanced NSCLC immediately after use of standard platinum-based chemotherapy in patients who had a response or had stable disease as result of the treatment.
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