Clinical trial: NCT01652469
Section: Alternatives
Subsections: Alternative Treatments

Instead of being in this study, your doctor may recommend that you receive Tarceva or another form of treatment (for example chemotherapy and/or radiotherapy) not given as part of this study.
Clinical trial: NCT01652469
Section: Confidentiality
Subsections: Confidentiality

The researchers will need to collect personal information from you such as your age, gender and relevant health information. All information collected is coded in a way that without a key, it will not be possible to link the information to your person. Any personal or health information that is collected will be kept private and confidential. It will be stored securely. Only authorised persons, who understand that it must be kept confidential, will be able to get access to it. In any report of the research made available to the public you will not be referred to by name. Representatives of ETOP, Biodesix Inc., health authorities or drug regulatory agencies may require access to personal or health information contained in your medical records to verify clinical trial procedures and/or data. Your personal data will be stored in a database and evaluated at the Data Centre of ETOP. ETOP guarantees that the national and international data protection guidelines are respected.
Clinical trial: NCT01652469
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts|Pregnancy/Birth Control:

While you receive treatment with the medications being used in the protocol, you are at risk of the side effects of these treatments. Your physician will be checking you closely to see if any of the side effects are occurring. You should report any side effect or symptom that you experience to your physician. Other drugs may be given to make some of these side effects less serious and uncomfortable.

All women who participate in the trial and are able to become pregnant must use effective contraception while they receive study medication and 12 months thereafter. If you are female and are pregnant, or plan to become pregnant, or if you are breastfeeding. you will not be allowed to enter this study. This is because the effects of the drug used in this study to an unborn baby or nursing infant are uncertain. You will also be asked to use a proven contraceptive method (a way to prevent you from becoming pregnant) while you are in this study. Your doctor will discuss with you which methods constitute effective contraception. If you are a man whose partner can get pregnant, you and your partner will need to use a proven contraceptive method while you are in this study.  
If you are female and become pregnant, or if you are male and a partner becomes pregnant, you must tell your study doctor immediately. For female patients, your doctor may discuss with you the possibility of stopping study treatment. Your doctor will need to report this information and the outcome of you or your partner's pregnancy to the ETOP safety office.
Clinical trial: NCT01652469
Section: Procedures
Subsections: Description Of The Clinical Research Study

Veristrat testing: If you decide to participate, a 3.5 mL blood sample will be collected for VeriStrat testing before randomization and will be sent to a central laboratory, called Biodesix, in Aurora, Colorado, USA. Neither you nor your doctor will be informed about the result of the test.There is a small possibility that your sample cannot be analyzed due to technical reasons. In this case you will be asked to give one additional blood sample. If this can also not be analyzed you will not be able to participate in this study. You will have a full medical history taken, physical examination, radiological and lab workout performed at the time you enter the study. If you are a female of childbearing potential, a pregnancy test will be done on your blood serum within 7 days prior to receiving study treatment. If you decide to participate in the study and meet the criteria to take part in the study described above, you will receive one of the following treatments: A: Tarceva®: 150 mg orally, daily. You will take Tarceva tablets every day. Tablets should be taken at a fixed time each day and at least 1 hour before or 2 hours after you eat.  
B: Docetaxel: 75mg/m2intravenous (IV) infusion received on one day every 3 weeks.  
Each period of 3 weeks is called a 3-week cycle. To reduce the risk of fluid retention and allergic reaction to this treatments, all patients will receive corticosteroids for 3 days starting one day before every Docetaxel administration. It is not clear at this time which treatment schedule would be better for you. For this reason, the treatment offered to you will be chosen by a method called randomization. Randomization is a method similar to the "flip of a coin" to assign at random (by chance) a treatment for you. Neither you nor your doctor can choose to which treatment arm you will be allocated: You will have an equal chance of being placed in one of the two groups. During the study treatment, you must visit your treating physician every 3 weeks for a physical examination. If you have been randomized to receive Tarceva, please bring with you all empty, full and partly used boxes of Tarceva® tablets. Routine blood analyses including liver and kidney function will be carried out every 3 weeks as part of standard medical routine. If you develop side effects, more frequent examinations may be necessary. Inpatient admission into a hospital is not foreseen, but can potentially become necessary. Your treating physician will document your general condition and all hospital stays during the clinical research study. He/she will similarly ask you about all side effects you have experienced and about all medications, supplements or treatments you have taken/received since your last visit.  
To determine the status of your NSCLC and effects from the treatment, radiological examinations (computer tomography [CT] of the chest) will be conducted at study entry and every 6 weeks thereafter (at the beginning of cycles 3,5,7,9 etc) until your tumour grows again. These examinations are carried out as part of medical routine and may be carried out more frequently, if your treating physician considers this appropriate. Your doctor may suggest other tests, such as CT of the brain. The regular doctor's visits are part of your standard medical care and are handled the same way as if you did not take part in the study.
Clinical trial: NCT01652469
Section: Purpose of Research
Subsections: Purpose Of The Research Study

You have been diagnosed with a type of lung cancer that is called "non small cell lung cancer (NSCLC)". Your lung cancer has recently recurred despite previous treatment with chemotherapy. Your doctor has decided that further treatment of your cancer is necessary.  
In previous clinical studies of NSCLC, treatment with Taxotere®(Docetaxel) showed a survival advantage in patient with advanced, relapsed NSCLC. Relapsed means that despite treatment, the cancer is growing. Similar results have been reported the treatment with Tarceva®(Erlotinib).  
The aim of the current study is to compare the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of these two treatments in patients with advanced NSCLC. Also, the aim is to explore how well the VeriStrat®
test is able to predict the response of NSCLC to one of the two drugs, Docetaxel and Erlotinib. VeriStrat is a test that will look for certain proteins in your blood that are related to your cancer, prior to receiving treatment with drugs such as Erlotinib. The results of the test have been shown to correlate with how well a tumour responds to treatments such as Erlotinib. VeriStrat is currently marketed in the USA as a test for patients with advanced NSCLC whose tumour has grown after previous treatment. Docetaxel and Tarceva are both approved by the Health Authorities in Europe and Switzerland for the treatment of NSCLC. EMPHASIS is an international clinical research study. A total of 500 patients from centers throughout Europe and Switzerland are expected to be enrolled in this study over a period of 18 months. In *country* it is planned that xx patients will take part. The study will take approximately 42 months to be completed. This clinical trial is conducted according to all applicable national laws and international guidelines. The trial has been approved by the independent Ethics Committee concerned *insert name of the Ethics Committee.*
Clinical trial: NCT01652469
Section: Voluntary Participation
Subsections: Voluntary Participation/Right To Refuse Or Withdraw

Your participation in this clinical research study is entirely voluntary. If you decide not to participate in the study, this will not affect your medical care in any way. If you begin the study, you will have the right to withdraw at any time without giving any reason. This will not affect your future medical care. You will be asked to have a final examination before you withdraw and you will be advised for other available care which suits your needs and medical condition. If you should withdraw, data already collected until then will be used for analysis.  
If you participate in the study, you should follow the instructions of your treating physician, follow the schedule of treatment visits, inform your physician of any new signs and symptoms you have, and about any non-study medication or supplement you take.
Clinical trial: NCT01652469
Section: Withdrawal from Study
Subsections: Termination Of The Study

You might stop receiving study treatment without your consent for the following reasons:
a) If your lung cancer worsens or a new tumour develops.  
b) If the doctors treating you detect side effects that they consider dangerous. c) If you refuse to have the treatments or follow-up examinations and tests needed to determine whether the treatment is safe and effective.  
d) If the early analyses of study data show insufficient benefit or a significant potential harm of the treatment.