Subject Information and Consent Form
A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer
| Qualified Investigator: | [Insert name and contact information] |
| Sub-Investigator(s): | [Insert name(s) and contact information, if required] |
| Sponsor: | Eli Lilly Canada Inc. |
Introduction
You are being invited to take part in a research study (also called a clinical trial). This research will study a drug known as pemetrexed (Alimta®). It is your choice if you want to be in this study or not. Research studies are different from regular care. Research studies are ways of finding out new information that might help other people with similar conditions or illnesses to yours. This form explains why we are doing the study, and how the treatment that is being offered to you is different from regular care. It tells you what will happen during the study. It also tells you about any inconvenience, discomfort or risk with this study. It also gives you a complete description of the treatment offered. This information will help you decide whether you wish to be part of the study.
What Is The Purpose of The Study?
The main reason for doing this study is to help answer the following research question:
- Whether the administration of pemetrexed as a maintenance treatment will improve upon therapy you initially received (pemetrexed in combination with cisplatin) and will prevent your cancer from growing or recurring.
Who Can Take Part In The Study?
To take part in this study you must have the diagnosis of unresectable, locally advanced, stage IIIB or stage IV, non-squamous non-small cell lung cancer. The study doctor or study staff has discussed with you the requirements for being in this study. It is important that you are completely honest with the doctor and staff about your health history. You should not take part in this study if you do not meet all requirements.
You cannot participate in this study if:
- You have an active infection or other serious condition such as cardiac disease
- You have had another malignant cancer less than five years ago
- You take aspirin or aspirin like medication that you are unable to stop taking for a few days during each cycle of therapy
- You are unable or unwilling to take folic acid, vitamin B12 and dexamethasone or other corticosteroids medication.
- You have had a yellow fever vaccination within the last 30 days or plan to have it.
Version: 26-October-2009
