Clinical Trials

Lung Protocols

As of July 24, 2012 - protocols do open and close daily. 
Please check with your physician for additional protocols and/or information.

1. S0709: Phase II Selection Design of Pharmocodynamic Separation of Carboplatin/Paclitaxel/OSI-774 or OSI774 Alone in Advanced NSCLC Pts with PS 2 Selected by Serum Proteomics

The purpose of this study is to find out whether a pill, OSI-774 (erlotinib), with or without chemotherapy (carboplatin and paclitaxel) would be effective in controlling your lung cancer by either shrinking the tumor or preventing it from growing.

2. CALGB 30801: A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Expressing Advanced Non-Small Cell Lung Cancer

The purpose of this study is to compare the effects, good and/or bad, of adding an experimental drug, celecoxib, to chemotherapy. This research is being done because current standard treatments for your type of lung cancer are usually not effective in preventing the cancer from growing. In this study we will test a sample of your cancer to see if it has an enzyme called COX-2. It is thought that cancers that have high levels of this enzyme may benefit from the addition of celecoxib to standard chemotherapy.

3. E5508: A Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or Both Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Stage Non-Squamous Non-Small Cell Lung Cancer

The purpose of this study is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer. Maintenance therapy is usually given after 4 cycles of standard chemotherapy (1 cycle = 21 days) to keep the disease under control for a longer duration. This study will compare the effects, good and/or bad, of bevacizumab, pemetrexed or the combination of the two agents when given as maintenance therapy.

4. N0923: A Randomized Double-Blinded Phase II Study of NTX-010, A Replication-Competent Picornvirus After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients with Extensive Stage Small Cell Lung Cancer

The purpose of this research study is to:

• Find out if NTX010 will help improve survival.
• Find out what effects, good and/or bad, NTX-010 has on you and your small cell lung cancer.
• Find out if there are individual differences and/or tumor characteristics that will affect response to treatment.

The agent, NTX-010, a live virus, used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However, the National Cancer Institute and the FDA have approved the use of this agent for this study.

5. E1505: Phase II Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Completely Resected Stage IB-IIIA NSCLC

This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).

The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back. Bevacizumab is investigational, which means it has not been approved by the FDA for use in this cancer.

6. CALGB 30607: Randomized Phase III Placebo Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial 4 Cycles of Platinum-Based Combination Chemo in Advanced Stage IIIB/IV NSCL

The purpose of this study is to determine whether or not giving you a drug called sunitinib after you respond to chemotherapy (your tumor shrinks or stops growing) will help your tumor continue to shrink, or stay the same. Sunitinib is experimental (investigational) in the treatment of non-small cell lung cancer. Standard treatment for your type of cancer after you receive initial treatment would be to consider therapy with pemetrexed, which is FDA approved for treatment after chemotherapy (also called maintenance therapy), or to stop chemotherapy treatment. In this study, you will get either the sunitinib or the placebo (a substance that looks like sunitinib, but contains no medication). You will not get both.

For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133