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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 3 Trial, Randomized, Open-Label, of NOV-002 in Combination With Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Brief 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.


Detailed Summary:

NSCLC is a widespread disease with extremely high mortality and morbidity. Even the most widely accepted standard of care chemotherapy in advanced NSCLC, platinum-based doublets, are only palliative, providing marginal efficacy as measured by survival. In addition, such chemotherapy is accompanied by severe, sometimes life-threatening, toxicities which often limit its application. Thus, there is a clear need for new, more effective and safer therapies for advanced NSCLC. In Phase 2 trials, NOV-002 demonstrated a higher response rate and improved survival compared to chemotherapy alone in patients with advanced NSCLC, and was well-tolerated in this patient group. Thus, we are conducting a large Phase 3 trial of NOV-002 to better define its clinical profile and potential benefit in advanced NSCLC patients.

The overall design of this Phase 3 trial reflects major elements of the previous Russian and US clinical trials in advanced NSCLC - it is an open label, randomized controlled trial comparing NOV-002 in combination with first-line chemotherapy (paclitaxel + carboplatin) to first-line chemotherapy alone. Furthermore, it is designed and powered to be a pivotal, registrational trial, sufficient for approval. As its primary efficacy endpoint, this Phase 3 trial aims to demonstrate that the combination of NOV-002 with paclitaxel and carboplatin results in improved overall survival when compared with paclitaxel and carboplatin alone. In addition, several secondary efficacy endpoints will be assessed, including progression free survival, tumor response rate and duration of response, quality of life, myelosuppression and immunomodulation. Overall survival was chosen as the primary endpoint of this trial in the context of FDA (Draft) Guidance ("Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics", April 2005). This Guidance indicates that an improvemen
Sponsor: Cellectar Biosciences, Inc.

Current Primary Outcome: Overall survival during the length of the trial, length of the trial is approximately two years after last patient in [ Time Frame: 16 months ]

Original Primary Outcome: Overall survival

Current Secondary Outcome:

  • Improved progression-free survival (PFS) [ Time Frame: 16 months ]
  • Higher anti-tumor overall response rate (ORR) [ Time Frame: 16 months ]
  • Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression [ Time Frame: 16 months ]
  • Immunomodulation as evidenced by changes in lymphocyte subsets [ Time Frame: 16 months ]


Original Secondary Outcome:

Information By: Cellectar Biosciences, Inc.

Dates:
Date Received: June 29, 2006
Date Started: November 2006
Date Completion:
Last Updated: November 7, 2011
Last Verified: March 2010