Immunization of Patients With Non Small Cell Lung Cancer (NSCLC)

Summary

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. If 3 or more responses are observed, the study will proceed to the second stage, accruing an additional 22 patients. If the second stage is complete and a total of 9 or more immunologic responses are observed among the 37 patients treated, the treatment response rate for the vaccine will be considered high enough to warrant further study. Conversely, if the evaluation of the vaccine concludes at the first stage, or if 8 or fewer total immunologic responses occur after completing the second stage, the vaccine will not be considered for further study.

Timeline

Start

2008-12

Primary completion

2010-09

Completion

2015-11

Outcome

Outcome not reported

Stopped (Enrollment): “study closed due to low enrollment”

Drugs

Indications