Clinical trial: NCT02839681
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study  
Taking part in another study Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT02839681
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
National Cancer Institute Institutional Review Board  
Qualified representatives from Bayer HealthCare Pharmaceuticals, Inc., the pharmaceutical company who produces BAY 94-9343 (anetumab ravtansine).
A description of this clinical trial will be available on http://www.Clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most the Web site will include a summary of the results. You can search this Web site at any time. Certificate of Confidentiality To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
will be used for auditing or program evaluation internally by the NIH; or must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
is necessary for your medical treatment and you have consented to this disclosure; is for other research.  
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT02839681
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In This Study?

Since not all lung cancers are positive for mesothelin up to 55 participants will be tested for mesothelin, and ~ 26 of these will receive study therapy.
Clinical trial: NCT02839681
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT02839681
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation Risks From Anetumab Ravtansine|Risks From Tumor Biopsies|Risks From Eye Examinations|Potential Benefits Of Participation

As with any drug administered, side effects may occur with the study drug anetumab ravtansine. As of 13 July 2017, a total of 411 patients have already received the study drug in different dosages in different studies. The following side effects have been reported from 323 patients who received anetumab ravtansine alone in all doses and all regimens without combination partners. The most common side effects (10% or more study subjects have experienced these side effects):  
Fatigue Nausea Diarrhea Decreased appetite Eye disorder (e.g., dry eye, blurred vision, eye redness, eye irritation) Vomiting Abnormal liver tests Numbness, tingling and burning pain usually in hands, legs and feet Between 1% and 10% of study subjects have experienced these side effects:
Muscle pain, cramp, and muscle weakness  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
Low platelet count (may lead to easy bleeding and bruising if severe)
Decrease in the number of red blood cells which can cause tiredness or shortness of breath Low white blood cell count (may lead to infection)
Reaction to drug infusion (could present as rash, hives, swelling, flushing, trouble breathing, faster heart beats)
Joint pain Abnormal blood test of pancreas function Abnormal taste sensation (for example, metallic taste)
Heart burn (gastroesophageal reflux)
Chest pain not related to heart Decreased thyroid function (presenting as cold intolerance, modest weight gain and low body temperature)
Night sweats Abnormal electrical activity of the heart (abnormal electrocardiogram/ECG) Increased levels of uric acid
Less than 1% patients experienced these side effects:  
Mouth sores Presence of protein in urine
Two cases reported side effects with a fatal outcome which were considered related to the study drug by the reporting investigator. One case reported liver failure in which the patient had extensive late stage pancreatic cancer with widespread liver metastasis. The other case was an infection of the blood (sepsis). You may ask your study doctor for detailed information about the side effects caused by the study drug anetumab ravtansine. You will be notified of any new side effects that occur during the time you are in the treatment phase of this study that may affect your decision to continue in this research study.

A numbing agent will be given prior to any tumor biopsy in order to prevent painful sensations. However, it is possible that you will experience pain or discomfort at the biopsy site. Irritation, redness, swelling and/or bleeding may also occur. There is a risk of abnormal healing, fever, infection or of an allergic reaction to the anesthetic agent used to anesthetize the skin at the biopsy site. Once the sample has been obtained, a stitch may be used to close the wound and facilitate healing.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
In some cases, we may use CT scans to help guide us during your biopsy. This introduces the added risk of research radiation. This research study may involve exposure to radiation from up to 2 CT guided tumor biopsies. This radiation exposure is not required for your medical care and is for research purposes only. The amount of radiation you will receive in this study is 0.29 rem which is below the guideline of 5 rem per year allowed for research subjects by the NIH Radiation Safety Committee. The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil. If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects. While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe. There may be a very slight increase in the risk of cancer. Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body.

You will have a strong light pointed in your eyes and this may cause mild and short-lived discomfort which is completely reversible and doesn't cause damage. The eye exam will require dilatation (widening) of your pupils (dark part in the front of the eye) by medicated eye drops. This dilatation of the pupils will prevent you from driving or operating machines for several hours after the eye exam, and will make your eyes sensitive to bright daylight and sunshine.  
Wearing sunglasses may be necessary for several hours after the eye exam. These effects of dilatation of the pupils are completely reversible after several hours. In order to test your tear production, you may be asked to remove your contact lenses and you may receive a local anesthetic eye drop.

The aim of this study is to see if this experimental treatment will cause your tumors to shrink. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT02839681
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study|During The Study

Before beginning the study, you will need to have tests and/or procedures to help your doctor decide whether you can take part. This is called screening. Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests that you will need to have if you take part in this study. If you have already had some of these examinations very recently, your doctor may decide not to repeat them. The screening will be done in two parts. Part 1 consists of the following:  
Medical history and physical examination You will provide us with sample of your tumor from a previous surgery or biopsy so that we may confirm your diagnosis and so that we may test for mesothelin. If a sample is not available, you will be required to have a biopsy, a procedure to remove a piece of tumor tissue from your body.
If the results of these tests show that you are not eligible for the study, we will remove you from the study. If the results show that you are eligible, you will continue to part 2 of screening. It is possible that several months may elapse between part 1 and part 2 while you complete your current treatment regimen.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
Please be aware that the test that will be used in this study determine the mesothelin status of your tumor is experimental (Investigational Device) and is limited by United States law to experimental use. Experimental means that the test is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Part 2 consists of the following:  
Medical history and physical examination Tests for hepatitis HIV testing: As part of this study, we will test you for infection with the human immunodeficiency virus (HIV), the virus that causes AIDS. If you are infected with HIV you will not be able to participate in this study. We will tell you what the results mean, how to find care, how to avoid infecting others, how we report HIV infection, and the importance of informing your partners at possible risk because of your HIV infection.  
CT scan or MRI
FDG-PET scan - an imaging technique during which a small amount of a radioactive substance is injected in your blood so that the scan can produce images of your tumor(s).  
Echocardiogram Electrocardiogram (ECG)
Eye examination that includes:
o tests of your vision o measurement of the pressure in your eye o test of tear production (dry eye test) o an examination of the various parts of your eye under a bright light (slit-lamp test)
Routine blood and urine tests Pregnancy test in women who can have children (you will not be allowed to take part if you are pregnant)
If the results of these tests show that you are not eligible for the study, we will remove you from the study. If the results show that you are eligible, you will continue to the treatment portion of the study.

In the run-in portion of the study, which will include the first 6 subjects enrolled, the highest planned dose of anetumab ravtansine will be tested. If fewer than 2 persons have intolerable side effects, this dose will be chosen as the phase 2 dose. If 2 or more persons have intolerable side effects, the next lower dose will be chosen as the phase 2 dose.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
In either part of the study, you will receive anetumab ravtansine through an IV (a tube inserted in a vein, usually in your arm) on day 1 of each 21-day cycle until you meet any of the conditions in the stopping therapy section on page 9. While you are on study therapy, we will perform tests and exams for safety and to find out about the effect of the study drug. These may include a physical exam, routine urine tests, pregnancy tests (if you are woman who can have children) and eye tests as described in the screening section each time you receive the study drug. ECG testing will be performed on the first day of cycle 1 after you receive the study drug and on the first day of cycle 2, both before and after you receive the study drug. Routine blood tests will be done weekly during cycle 1 and on days 1 and 8 of the rest of the cycles. (Some of these may be done by your local laboratory). You will also have scans (FDG-PET scan and CT scan or MRI) every 6 weeks during the first 6 months, then every 9 weeks until the end of year 2, then every 12 weeks. An echocardiogram will be performed every 6 weeks during the first 6 months, then every 12 weeks. In addition to the safety tests, we will also perform tests for research studies on your blood and tumor tissue.  
We will collect blood for research studies before you have begun study therapy, on day 1 of cycle 3 and at the end of therapy.  
We will collect optional biopsies before you have begun study therapy (if you have not had a biopsy at screening) and after you have completed two cycles of therapy. The biopsies are exclusively for research purposes and will not benefit you. It might help other people in the future. You will have the chance to decide whether you want to have these samples collected at the time of each biopsy.  
Leftover tissue from the sample from a previous surgery that you provided at screening will also be used
Clinical trial: NCT02839681
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

Anetumab ravtansine is an investigational drug, meaning that it has not been approved by the US Food and Drug Administration. It is a drug that kills cancer cells that carry mesothelin, a protein PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
- Adult Patient or - Parent, for Minor Patient NIH-2514-1 (07-09)
P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)
found on the surface of tumor cells in many types of tumors, including a majority of lung cancers. This study comprises two parts: the first part of the study, called the run-in portion of the study, is designed to find a safe dose with this experimental drug in your disease. This is done because the drug has been tested in other diseases but not in lung cancer. Six patients will be included in this part of the study. The second part of the study, called a phase 2 study, will further test the safety of the drug in lung cancer and determine if anetumab ravtansine can shrink tumors in mesothelin-positive lung cancer.
Clinical trial: NCT02839681
Section: Withdrawal from Study
Subsections: When You Are Finished Taking The Drugs|Stopping Therapy

About 30 days after you have had your last dose of study drug, you will return to the NIH for a follow up visit to have the following tests:  
Medical history and physical exam Routine blood tests Pregnancy test (if you are a woman who can have children)
ECG
Eye exam (as described in the screening section)
After the safety visit, we will also contact you or your physician about once every three months by telephone to ask about any other cancer therapies you may have started and about your survival status.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent

Your doctor may decide to stop your therapy for the following reasons:
if he/she believes that it is in your best interest  
if you need treatment that is not allowed on the study if you become pregnant  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
if he/she decides to stop the study if your disease comes back during treatment and he/she does not think you are benefitting from the study therapy if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you In this case, you will be informed of the reason therapy is being stopped.
You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first.  
If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to Bayer HealthCare Pharmaceuticals, Inc. or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.