Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/2

 * You have excess fluid around your lungs or in your abdomen that cannot be removed prior to study entry

If you are a woman and could become pregnant, you must talk to the study doctor about birth control. You must avoid getting pregnant during the study and for 6 months after the study is completed. If you are planning to get pregnant during the study, you should not take part.

If you are a man, you must avoid the chance of your female partner becoming pregnant during the study and for 6 months after the study is completed. The study doctor will discuss birth control with you.

''' What Does The Study Involve? ''' About 900 study subjects will be taking part in this study.

Your participation in this study is expected to last until you or your physician decides that there is no clear benefit for you to continue treatment. However, your physician will ask you afterwards to visit him on regular basis to follow-up on your health status. The expected minimal trial duration would be approximately 16 weeks (if only part 1).

If you decide to take part in this study, the procedures and visits you can expect are explained in the attachment called Study Procedures - Attachment 1. This will give you information about what taking part in the study will mean to you, for example, how often you have to come to see the study doctor, how long each visit might take, when blood samples will be taken and when tests and procedures will be performed.

Treatment Assignment This trial consists of 2 parts.

During the first part you will be administered 4 intravenous infusions of pemetrexed in combination with cisplatin (approximately 3 weeks apart).

If you have benefited from this therapy, you will then enter the second part of the trial. You'll be assigned to receive either pemetrexed or placebo (a saline solution that has similar appearance to the study drug but has no medicine). Each pemetrexed or placebo (normal saline) intravenous infusion will be repeated approximately every 3 weeks. Whatever treatment you're assigned to, you will also receive Best Supportive Care (BSC) which is defined as treatment given to maximize quality of life without the intention of stopping your cancer to grow.

The treatment you will receive will be determined by chance (like flipping a coin). Neither you nor your doctor will be able to choose which treatment you will receive. You will have twice the likelihood of receiving pemetrexed than placebo. Once you are assigned to a treatment neither you nor the study doctor will know what medication you are receiving.

You will continue to receive this treatment, BSC + pemetrexed or BSC + placebo, until the status of disease worsens, you have significant side effects or your doctor believes that it is in H3W-EW-S124 (b) Version: 26-October-2009