Non-small cell lung cancer (NSCLC) is a disease in which cancer cells multiply to form tumors in the lung and can then spread to other parts of the body.
NSCLC is said to be "advanced" when it has spread to the lymph nodes, the other lung, or other areas of the body.
ASA404 is an investigational medication in clinical development by Novartis. At this time, ASA404 is available only to cancer patients in clinical trials such as ATTRACT-1 because it has not been approved by regulatory authorities in any country. Research in animals has shown that ASA404 can interfere with cancer growth. In an earlier clinical trial, ASA404, in combination with standard chemotherapy treatment (paclitaxel and carboplatin), was found to improve survival in some patients with NSCLC. However, individual results may vary and there is no guarantee that participants will benefit by participating in the ASA404 studies. ASA404 is given in the doctor's office or clinic as an intravenous (in the vein) infusion after your chemotherapy.
ATTRACT-1 stands for Antivascular Targetd Therapy: Researching ASA404 in Cancer Treatment. This study is testing the effectiveness and safety of ASA404 in combination with paclitaxel and carboplatin, 2 chemotherapy drugs that are used to treat NSCLC.
*ASA404 (formerly AS1404, DMXAA) is licensed from Antisoma.
The goal of the ATTRACT-1 clinical trial is to learn whether ASA404, when given together with paclitaxel and carboplatin, can improve survial in patients with advanced NSCLC compared with paclitaxel and carboplatin alone. Your physical state, changes in your cancer, and laboratory findings observed during the study will help determine if ASA404 is safe and effective in the treatment of advanced NSCLC.
You may be eligible to participate in this study if you have been diagnosed with advanced NSCLC that has not yet been treated. In addition, you must be an adult 18 years of age or older to participate in ATTRACT-1. There are other eligibility requirements that your doctor can review with you if you are interested in participating in this study.
If you qualify for the ATTRACT-1 study and decide to participate, you will be randomly assigned (selected by chance) to 1 of 2 different treatment groups. Both groups will be treated with paclitaxel and carboplatin, and 1 of the groups will also receive ASA404. Your treatment group will be kept secret from you and your doctor. It is important to follow all the instructions given to you by your doctor during the entire study period. You will also be expected to attend all scheduled office visits and to report any side effects you experience.
Patients who participate in this study will be monitored closely throughout their treatment by trained doctrs and nurses who specialize in lung cancer research and treatment.
While participating in this study, you may experience side effects from your treatment. Side effects will vary from person to person. Possible side effects are listed below.
Your doctor and nurse will monitor you during the study to identify any side effects and take appropriate action to treat them. It is important that you report any side effects you may experience to your doctor or nurse.
Patients in the ATTRACT-1 study will be active participants in contributing to lung cancer research that may help other patients in the future. Treatment in this clinical trial may slow the growth of your cancer. However, you must also be aware that participation in this study may not benefit you. You should talk to your doctor about all your treatment options.
Informed consent is the process by which a patient is given detailed information about a clinical trial before deciding whether or not to participate. This process guarantees that you will be given any additional information that may become available throughout the study period that may affect your participation in the study.
You will be given an informed consent document. This document includes clinical trial details, risks and benefits, and an explanation of your rights as a clinical trial participant. Study participation is voluntary. You may discontinue your participation in a clinical trial at any time. Please ask your doctor or nurse for more information about your rights as a clinical trial participant.
Clinical trials help to determine whether new therapies, or new ways of using existing therapies, can improve the treatment of diseases. All new therapies undergo a thorough review process before they are made available to the general public. Every country has its own review process.
For more information about ATTRACT-1 and ASA404, please visit www.attractstudy.com or call the Novartis Oncology Clinical Trials Hotline at 1-800-340-6843.
Information about lung cancer and its treatment may be found at
Expanded information on clinical trials can be found at www.cancer.gov/clinicaltrials/learning/
© Novartis 2008
