drugset / Trial / NCT00347412

Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer

NCT00347412 ↗

Phase 3 Completed 903 enrolled Cellectar Biosciences, Inc.
RandomizedFactorialOpen-labelTreatment

Summary

The purpose of this clinical trial is to find out whether or not the combination of NOV-002 with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC). Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination with chemotherapy had a better response (their tumors got smaller in one United States Phase 1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had a better survival rate than patients who did not receive NOV-002 with their chemotherapy.

Timeline

Start
2006-11
Primary completion
2010-01
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject NOV-002 Unknown 60 mg Intravenous
Background Carboplatin Small molecule 6 unknown —
Background Paclitaxel Small molecule 200 mg/m2 Intravenous