Clinical trial: NCT03033511
Section: Alternatives
Subsections: Alternatives

You do not have to participate in this study to get help for your condition.  
Alternatives to this study for the treatment of your condition may include drugs already approved or being used for treatment of your condition, surgery or other experimental drugs.  Your study doctor can discuss the risks and advantages of these alternative treatment methods with you.  In addition, you may discuss your otions with your regular health care provider.
Clinical trial: NCT03033511
Section: Confidentiality
Subsections: Confidentiality

We will keep your name and all the information about you used in this study as confidential as possible.  We may publish the results of this study for others to read about, but you will not be identified in any articles about the study by name, social security number, address, telephone number, or any other direct personal identifier.  Also, other federal agencies as required, such as the VA Office of Research Oversight and the VA Office of the Inspector General may have access to your information. Because this study involves an investigational drug, the Food and Drug Administration may also have access to information about you collected in this study.
Clinical trial: NCT03033511
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

Your participation in this study will last until your disease worsens or you no longer tolerate rovalpituzumab tesirine and dexamethasone or placebo treatment and may last approximately 12 months and include 12 study visits to the
Clinical trial: NCT03033511
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:
Follow the instructions of the investigators and study staff.  
.  
Take the study drug as instructed.  
.  
Keep your study appointments.  If it is necessary to miss an appointment,
.  
please contact the investigators or research study staff to reschedule as soon as you know you will miss the appointment.  
Tell the investigators or research study staff about any side effects, doctor
.  
visits, or hospitalizations that you may have.  
Tell the study doctor if you have any changes in medications during the
.  
study, or if you are planning to change any medications during the study.  
Do not change any of your medications or start any new medications
.  
without checking with your study doctor Tell the investigators or research staff if you believe you might be
.  
pregnant or gotten your partner pregnant.  
Keep the study drug in a safe place, away from children and for your use
.  
only.  
Refrain from participation in other research studies while you are subject
.  
in this study.  
Page 15 of 29  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
.  
Fill out your dosing sheet, questionnaires and diary completely and honestly and bring it to the study doctor's office at each visit.  
Complete the subject diary as instructed and bring with you to each clinic
.  
visit.
Do not share your study drug with anyone.  You are the only person
.  
allowed to take the study drug.  
Keep the study drug and study supplies out of the reach of children and
.  
persons of limited ability to read or understand.  
. .  
Ask questions as you think of them.  
Tell the investigators or research staff if you change your mind about staying in the study.
Clinical trial: NCT03033511
Section: Participant's Rights
Subsections: Participant'S Rights|Experimental Subject'S Bill Of Rights

You should not feel obligated to agree to participate.  Your questions should be answered clearly and to your satisfaction.  
Page 24 of 29  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

As a research participant you have the following rights.  These rights include but are not limited to the participant's right to:
be informed of the nature and purpose of the experiment;
.  
be given an explanation of the procedures to be followed in the medical
.  
experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably
.  
to be expected; be given an explanation of any benefits to the subject reasonably to be
.  
expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that
.  
might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the
.  
subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the
.  
procedures involved; be instructed that consent to participate in the medical experiment may be
.  
withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and
.  
be given the opportunity to decide to consent or not to consent to a
.  
medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.  
  
Expiration Date:
Clinical trial: NCT03033511
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Rovalpituzumab Tesirine Discomforts And Risks:|Skin Side Effects:|Inflammation Of The Lungs:|Liver Side Effects:|Risks Associated With Dexamethasone:|Pregnancy, Breastfeeding And Birth Control:|Risks Related To Study Procedures:|Mri (Magnetic Resonance Imaging)|If You Feel Discomfort At Any Time, Notify The Operator And You Can Discontinue The Exam At Any Time. Potential Benefits

You may experience certain side effects and discomforts from taking rovalpituzumab tesirine.   You may have all, some, or none of the potential side effects.  There is also a possibility that you may experience other rare or unknown side effects.  Your doctors and nurses will check you closely for side effects, and may give you medicines or other treatments to stop or reduce some of these effects.  Some side effects may go away soon after the study drug is stopped, but in some cases, side effects may be serious, long lasting, and/or permanent. There is even a chance that a side effect may cause death.  
Rovalpituzumab tesirine has been tested in approximately 100 adult patients with cancer.  The side effects listed below are those that have been observed and may or may not be related to rovalpituzumab tesirine.   You may experience some of these side effects whether or not you are taking rovalpituzumab tesirine.  
The following side effects have been observed in >10% of patients receiving rovalpituzumab tesirine:
Fatigue (49%)
.  
Fluid buildup around the lung(s) (34%)
.  
Page 17 of 29  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
Shortness of breath (31%)
.  
Swelling of the legs or other areas of the body (30%)
.  
Decreased Appetite (26%)
.  
Nausea (26%)
.  
Constipation (26%)
.  
Diarrhea (22%)
.  
Vomiting (22%)
.  
Low red blood cell count (18%)
.  
Low albumin blood level (18%)
.  
Low platelet blood count (17%)
.  
Joint pain (17%)
.  
Cough (16%)
.  
Rash (15%)
.  
Fever (15%)
.  
Photosensitivity - an increased sensitivity of skin (e.g. rash or other
.  
reaction) to sunlight exposure (13%)
Abdominal pain (13%)
.  
Abnormal fluid buildup around the heart (13%)
.  
Superficial reddening of the skin (13%)
. .  
Increased level of lipase (an enzyme found in the pancreas) in the blood
(11%)
Fluid around the lungs or heart, or in the abdomen, and swelling in the limbs; Some patients treated with rovalpituzumab tesirine have experienced a buildup or worsening of fluid surrounding the lungs, and heart or in the abdomen.  
Shortness of breath, fatigue, and swelling of the limbs were sometimes reported with the excess fluid.  Tell your doctor immediately if you experience any of these symptoms. These side effects may interfere with your daily activities. The side effects may be life threatening, such as when too much fluid accumulates around your heart, preventing it from pumping blood effectively. You will be monitored throughout the study for these side effects.  If any side effects develop, you may undergo procedures to drain the extra fluid and/or be prescribed corticosteroids or other drugs to try to reduce the fluid. In some serious cases, and if buildup of fluid is not medically treated through drainage procedures, steroids and other drugs, it may lead to death.  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:

Some patients treated with rovalpituzumab tesirine have experienced rashes, typically associated with an increased sensitivity to the sun or ultraviolet light.  
This is called photosensitivity.  You are instructed to wear sun protective clothes, sunscreen, and otherwise avoid direct sun exposure. Other skin reactions observed in patients include redness, swelling and pain of the palms of the hands and soles of the feet, or a rash consisting of target-shaped spots.  If you notice any of these symptoms, tell your doctor. You will be monitored for this throughout the study and may be evaluated by a dermatologist if any of these symptoms appear. Hematological Side Effects:
Some patients who have received rovalpituzumab tesirine have had decreases in platelets, red blood cells, and/or white blood cells, which may have consequences such as prolonged bleeding, feeling tired or weak, and being more sensitive to infections. The level of these blood cells will be checked regularly.

One patient treated with rovalpituzumab tesirine experienced progressive inflammation and thickening of the lungs, which led to death. Tell your doctor immediately if you experience a shortness of breath and difficulty breathing. You will be monitored for any clinical symptoms that may be consistent with inflammation of the lungs.

In rare cases, patients who have been treated with rovalpituzumab tesirine have reported elevations in certain enzymes (proteins) found in the blood which may reflect an injury to liver cells. Sometimes these elevations are associated with fatigue, weakness, abdominal pain, loss of appetite, yellowing of the skin, itching, abnormal bruising, fluid accumulation, or confusion. Your liver enzymes will be routinely monitored throughout the study, but it is important that you report any of these symptoms to your doctor as soon as you notice them.

The most common side effects (occurring in ≥ 10% of patients) reported in subjects treated with dexamethasone are listed below. Additional risks outlined in Page 19 of 29  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
your local label (if applicable) should also be discussed. Common events include but are not limited to:
.  
Nausea
.  
Muscle pain or weakness Fatigue
.  
.  
Headache
.  
Swelling (edema)
.  
Confusion or mood changes
.  
High blood sugar (hyperglycemia)
.  
Stomach pain
.  
Weight gain
.  
Vision changes
.  
Sleep problems (insomnia)
Skin changes (hair growth, acne, slow wound healing, rash)
.

If you are pregnant or currently breast feeding, you may not participate in this study.  You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your child may be exposed to an unknown risk. To confirm to the extent medically possible that you are not pregnant, you agree to have a pregnancy test done before beginning this research study.  
If you are female, you must not get pregnant while in this research study and for at least 6 months after the last dose of the drug. The only certain way to not get pregnant is to not have sex. If you are a male or female able to have children and choose to have sex, you must use effective birth control while in this research study from screening until at least 6 months after the end of the study.  If you are male, you must agree not to donate sperm for at least 6 months after the last dose of drug. Effective birth control for female patients includes (a) combined, estrogen and progestogen containing, hormonal contraception (oral, intravaginal, transdermal)
associated with the inhibition of ovulation, initiated at least 1 month prior to Study Day 1 (randomization); (b) progestogen-only hormonal contraception (oral, injectable, implantable) associated with  the inhibition of ovulation, initiated at Page 20 of 29  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
least  1 month prior to  Study  Day  1 (randomization); (c) intrauterine device; (d)
intrauterine hormone-releasing system; (e) bilateral tubal occlusion; (f)
vasectomized partner; and (g) sexual abstinence (refraining from heterosexual intercourse) only when this is in line with your preferred and usual lifestyle. Male patients who are sexually active with females who are able to have children must use condoms (even if they are vasectomized) and his female partner (s)
must use at least one of the birth control methods described in the above paragraph.  
Even if you use birth control during the research study, there is a chance you could become pregnant. If you are pregnant or become pregnant during the research study, the study drug will be discontinued. The study drug or procedure may involve risks to the unborn baby, which are currently unforeseeable.  
The study drug has not been studied in pregnant women, so its effects are unknown.  
Because rovalpituzumab tesirine is investigational, all of its side effects may not be known. There have been additional toxicity seen in animal studies, such as kidney and liver toxicity. There may also be rare and unknown side effects, some of which may be irreversible and/or life threatening.  
There are no well-controlled studies on dexamethasone use in pregnant women.  
Dexamethasone is only recommended during pregnancy when there are no alternatives and benefits outweigh the risk.  
Please contact your study doctor if you become pregnant while taking dexamethasone.  
It is not known whether dexamethasone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, you should not nurse a baby while taking dxamethasone. If you think you are or your partner becomes pregnant during the study, you must tell the study doctor or study staff immediately.  You are responsible for informing your partner(s) of the risk and for reporting any pregnancy to your study doctor.  
Page 21 of 29

Tumor Material Biopsy:  Having biopsies performed may cause pain,
.  
bruising, bleeding, redness, low blood pressure, swelling, and/or infection at the site of the biopsies. An allergic reaction to the anesthetic may occur.  
A scar may form at the biopsy site. Ask your doctor or study staff of other potential effects on the area being sampled.  
Blood Testing:   Blood draws may cause pain, bleeding, and/or bruising.  
.  
You may faint and/or develop an infection with redness and irritation of the vein at the site where blood is drawn. Frequent blood collection may cause anemia (low red blood cell count), which may create a need for blood transfusions.  
Echocardiogram: there are no special risks of this test, apart from some
.  
discomfort from laying in the correct position to get test results Electrocardiogram (ECG):   Skin irritation is rare but could occur during an
.  
EG from the electrodes or gel that is used. To do the ECG, you will have pads placed on different parts of your body.  There is no pain on discomfort during an ECG; however, removing the pads may cause some irritation to your skin.  
MRI:   For most people, there is no danger associated with having an MRI
.  
scan.  However, an MRI could be very dangerous if you have certain objects or devices (usually metal) implanted in your body, such as a pacemaker, insulin pump, ear implant, joint replacement, permanent dentures, piercings, or shrapnel.  You must tell the study doctor or study staff about any objects that you know are implanted or embedded in your body. Some people may feel claustrophobic, so tell the study staff if you are claustrophobic. Physical Exam:   there are no special risks with an exam. It will be similar
.  
to examinations you have had in your doctor's office in the past.  
Pregnancy Testing:   the risks are similar with any blood test
.  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
.  
Patient Reported Questionnaires (PRO):   Filling out the questionnaires could lead you to feel uncomfortable or upset.  Please tell the study doctor or study staff if you feel uncomfortable or upset while filling out a questionnaire.  You have the right to refuse to answer any questions.  
Risks to DLL3 (Delta-like protein) testing: The test to determine your DLL3 status is new and is investigational use only at this time.  
.

MRI machines use a strong magnet and radiofrequency magnetic fields to make images of the body interior.  The scanning procedure is very much like an X-ray or CT scan.  You will be asked to lie on a long narrow couch for a certain amount of time (about an hour) while the machine gathers data.  During this time you will not be exposed to x-rays, but rather a strong magnetic field and radiofrequency magnetic fields, which you will not feel.  You will, however, hear repetitive tapping noises that arise from the Magnetic Resonance (MR) scanner.  We will provide earplugs or headphones that you will be required to wear.  The space within the large magnet in which you lie is somewhat confined, although we have taken many steps to relieve the "claustrophobic" feeling.  
Magnetic fields do not cause harmful effects at the levels used in the MRI machine.  However, the MR scanner uses a very strong magnet that will attract some metals and affect some electronic devices.  If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very important that you tell the operator/investigator immediately.  As metallic objects may experience a strong attraction to the magnet, it is also very important that you notify the operator of any metal objects (especially surgical clips), devices, or implants that are in or on your body before entering the magnet room.  All such objects must be removed (if possible) before entering the magnet room.  In some cases, having those devices means you should not have an MRI scan performed.  In addition, watches and credit cards should also be removed as these could be damaged.  You will be provided a way to secure these items.  If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop, or if you could be pregnant, you should notify the operator/investigator.  You should also notify the operator/investigator if you have any tattoos on your body.  Tattoos could become warm and irritated during the scan and remain so for several days.  
  
  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
If you would prefer not to participate in the MR scan due to the presence of tattoos on your body, please inform a research team member. If you have had a previous reaction to Gadolinium-based contrast agents or a history of severe allergies, please notify the operator/investigator.  If you have kidney problems, please tell the operator.  
It has been observed that deposits of Gadolinium-based contrast agent (GBCA) remain in the brains of some people who undergo four or more contrast enhanced MRI scans, long after the last administration. It is not yet known whether these Gadolinium deposits are harmful or can lead to adverse health effects.  You should talk to the study doctor if you have any questions about the use of GBCAs with MRIs.

You may or may not benefit from being in this study but your participation in this research study may benefit future patients with your disease or condition.  Your condition may get better, it may get worse, or it may stay the same.
Clinical trial: NCT03033511
Section: Procedures
Subsections: Procedures Screening|Study Activities Table

In order to determine if you are eligible to participate in the study you will complete the screening procedures (activities, tests and evaluations) described in this form. Such tests and evaluations are completed during a 21 day screening period that takes place before participation in the main part of the study. Most of these procedures are the same or similar to those that are normally performed as part of your regular cancer care.  
Informed consent– You will be asked to sign this consent form document. Medical/Oncology History - (including questions regarding your health problems, list of prescribed and over the counter medications/supplements
.  
that you are taking, details of your lung cancer diagnosis and previous treatment and questions regarding tobacco and alcohol use).  
Physical Exam– Complete physical exam.  
.  
Vital Signs (blood pressure, heart rate, and temperature), Weight, and
.  
Height EG (a test which records the electrical activity of your heart)
.  
Blood and urine tests to monitor your health –
.  
ooo Routine blood tests (approximately 2 teaspoons or 10 mL of blood)
to check your blood counts (numbers of each type of blood cell),
Page 2 of 29

| Survival                |                        |           |           |       |       |             |     |     |     |             |             |    |    |
|-------------------------|------------------------|-----------|-----------|-------|-------|-------------|-----|-----|-----|-------------|-------------|----|----|
| Non-Treatment Cycle     | End of                 |           |           |       |       |             |     |     |     |             |             |    |    |
| Screening               | Treatment (Each Cycle) | Visit     | Treatment | PTFU  | FU    |             |     |     |     |             |             |    |    |
| Weekly                  | within 7               |           |           |       |       |             |     |     |     |             |             |    |    |
| (Day 8, 15,             | days of                |           |           |       |       |             |     |     |     |             |             |    |    |
| Day 21                  | Day                    | Day       | Day       | Day   | Day   | Day         | Day | Day | Day | 2, 29, 36). | decision to | q6 | q6 |
| to Day –1.              | -1                     | 2         | . 22      | weeks | weeks |             |     |     |     |             |             |    |    |
| .                       | 8                      | 15.       | 29        | 36    | A     | discontinue |     |     |     |             |             |    |    |
| Category                | Procedures             | treatment |           |       |       |             |     |     |     |             |             |    |    |
| x                       | x                      | x         | x         | x     | x     |             |     |     |     |             |             |    |    |
| Location.               | Clinic Visit           |           |           |       |       |             |     |     |     |             |             |    |    |
| Phone Contact           | x                      | X         | x         | x     | x     | x           |     |     |     |             |             |    |    |
| Informed Consent        | x                      |           |           |       |       |             |     |     |     |             |             |    |    |
| Safety Assessments      | Medical and Surgical   | X         |           |       |       |             |     |     |     |             |             |    |    |
| History                 |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| Physical examination    | x                      | X         | x         | X     | x     |             |     |     |     |             |             |    |    |
| x                       | X                      |           |           |       |       |             |     |     |     |             |             |    |    |
| Vital Signs             | X                      | x         | X         |       |       |             |     |     |     |             |             |    |    |
| Routine Blood Tests     | x                      | x         | x         | x     | x     |             |     |     |     |             |             |    |    |
| (up to 10mL or 2 tsp)   |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| Urine                   | x                      | x         | x         | x     | x     |             |     |     |     |             |             |    |    |
| x                       | x                      | x         | X         | x     |       |             |     |     |     |             |             |    |    |
| Pregnancy Test*         | omL or 1 top           | urine     | trine     | ure   | urine |             |     |     |     |             |             |    |    |
| ot blood                |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| Electrocardiogram       | x                      | x         | x         |       |       |             |     |     |     |             |             |    |    |
| (ECG)                   |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| Echocardiogram          | x                      | x         |           |       |       |             |     |     |     |             |             |    |    |
| Performance Status      | x                      | x         | x         | x     |       |             |     |     |     |             |             |    |    |
| Fluid Retention         | x                      | x         | X         | x     | X     | x           | x   | x   | x   |             |             |    |    |
| Questionnaire           |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| (including daily weight |                        |           |           |       |       |             |     |     |     |             |             |    |    |
| dary).                  | Page 10 of 29          |           |           |       |       |             |     |     |     |             |             |    |    |  
  
W  Department of Veterans Affairs  
  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:  
| Survival                             |                        |           |             |      |     |     |       |                        |     |    |    |    |
|--------------------------------------|------------------------|-----------|-------------|------|-----|-----|-------|------------------------|-----|----|----|----|
| Non-Treatment Cycle                  | End of                 |           |             |      |     |     |       |                        |     |    |    |    |
| Screening                            | Treatment (Each Cycle) | Visit     | Treatment   | PTFU | FU  |     |       |                        |     |    |    |    |
| Weekly                               | within 7               |           |             |      |     |     |       |                        |     |    |    |    |
| (Day 8, 15,                          | days of                |           |             |      |     |     |       |                        |     |    |    |    |
| Day                                  | Day                    | q         |             |      |     |     |       |                        |     |    |    |    |
| Day 21                               | Day                    | Day       | Day         | Day  | Day | Day | Day   | 2, 29, 36) decision to | .q6 |    |    |    |
| to Day -1                            | -1                     | 2         | .15         | 22   | 29  | ,36 | weeks | weeks                  |     |    |    |    |
| 1                                    | 8                      | .1        | discontinue |      |     |     |       |                        |     |    |    |    |
| Category                             | Procedures             | treatment |             |      |     |     |       |                        |     |    |    |    |
| SAE/Adverse Events                   | SAE                    | x         | x           | X    | X   | x   | x     | X                      | x   | x  | X  | x  |
| Concomitant                          | x                      | x         | X           | x    | x   | x   | x     | x                      | x   | X  | x  |    |
| Medications                          |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Treatment                            | Rovalpituzumab         | x         |             |      |     |     |       |                        |     |    |    |    |
| tesirine or Placebo                  |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Infusion                             |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Dexamethasone or                     | x                      | x         | X           |      |     |     |       |                        |     |    |    |    |
| Placebo (orally twice                |                        |           |             |      |     |     |       |                        |     |    |    |    |
| daily approximately 12               |                        |           |             |      |     |     |       |                        |     |    |    |    |
| bours apart)                         |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Response Assessment Disease/Response | X                      | x         | x           |      |     |     |       |                        |     |    |    |    |
| X                                    | EX                     |           |             |      |     |     |       |                        |     |    |    |    |
| Assessment (CT                       |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Imaging)                             |                        |           |             |      |     |     |       |                        |     |    |    |    |
| MRI/CT of the Brain                  | X                      |           |             |      |     |     |       |                        |     |    |    |    |
| (may be repeated if doctor           |                        |           |             |      |     |     |       |                        |     |    |    |    |
| feels necessary)                     | X                      | x         | X           | x    | X   |     |       |                        |     |    |    |    |
| Patient Reported                     | (only                  | (1"NTC)   |             |      |     |     |       |                        |     |    |    |    |
| Outcome (PRO)                        | C2D1)                  | x         |             |      |     |     |       |                        |     |    |    |    |
| Heath Resource                       | x                      | X         | x           | X    |     |     |       |                        |     |    |    |    |
| Utilization                          |                        |           |             |      |     |     |       |                        |     |    |    |    |
| Survival Status                      | x                      |           |             |      |     |     |       |                        |     |    |    |    |  
Page 11 of 29 W Department of Veterans Affairs  
  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:  
| Survival                                      |                        |           |             |      |     |       |       |     |                           |    |
|-----------------------------------------------|------------------------|-----------|-------------|------|-----|-------|-------|-----|---------------------------|----|
| Non-Treatment Cycle                           | End of                 |           |             |      |     |       |       |     |                           |    |
| Screening                                     | Treatment (Each Cycle) | Visit     | Treatment   | PTFU | FU  |       |       |     |                           |    |
| . Weekly                                      | within 7               |           |             |      |     |       |       |     |                           |    |
| (Day 8, 15,                                   | days of                |           |             |      |     |       |       |     |                           |    |
| Day                                           | qo                     |           |             |      |     |       |       |     |                           |    |
| Day -21                                       | Day                    | Day       | Day         | Day  | Day | Day   | Day   | Day | 22, 29, 36)   decision to | q6 |
| to Day –1                                     | 2                      | 15        | 22          | 29   | 36  | weeks | weeks |     |                           |    |
| ..                                            | .8                     | -1        | discontinue |      |     |       |       |     |                           |    |
| Category                                      | Procedures             | treatment |             |      |     |       |       |     |                           |    |
| Pharmacokinetic                               | x                      | X         | x           |      |     |       |       |     |                           |    |
| (PK), Biomarkers,                             | Pharmacokinetics       | tre       |             |      |     |       |       |     |                           |    |
| and Pharmacogenetic [(PK) (6 mL or 1.2 tsp of | efuse                  |           |             |      |     |       |       |     |                           |    |
| (PG)                                          | ad post                |           |             |      |     |       |       |     |                           |    |
| infusion                                      |                        |           |             |      |     |       |       |     |                           |    |
| Tumor Material at                             | x                      |           |             |      |     |       |       |     |                           |    |
| Screening (Archived                           |                        |           |             |      |     |       |       |     |                           |    |
| or Fresh)                                     |                        |           |             |      |     |       |       |     |                           |    |
| Optional Tumor                                | X -                    |           |             |      |     |       |       |     |                           |    |
| X                                             |                        |           |             |      |     |       |       |     |                           |    |
| Material at Time of                           |                        |           |             |      |     |       |       |     |                           |    |
| Disease Progression                           |                        |           |             |      |     |       |       |     |                           |    |
| Blood for                                     | x                      | x         | x           | x®   |     |       |       |     |                           |    |
| inflammatory                                  | pee                    |           |             |      |     |       |       |     |                           |    |
| Markers (6 mL or 1.2)                         | efore                  |           |             |      |     |       |       |     |                           |    |
| top of blood)                                 |                        |           |             |      |     |       |       |     |                           |    |
| Blood for Tumor &                             | x                      | X         | X           | x    |     |       |       |     |                           |    |
| Soluble Markers (6                            | re                     |           |             |      |     |       |       |     |                           |    |
| mL or 1.2 tsp of blood)                       | efories                |           |             |      |     |       |       |     |                           |    |
| x                                             | x                      |           |             |      |     |       |       |     |                           |    |
| Circulating Tumor                             | Clock                  |           |             |      |     |       |       |     |                           |    |
| Cells (8 mL or 1.6 tsp of                     |                        |           |             |      |     |       |       |     |                           |    |
| (lood)                                        | tre                    |           |             |      |     |       |       |     |                           |    |
| inforice                                      |                        |           |             |      |     |       |       |     |                           |    |
| x                                             | X                      |           |             |      |     |       |       |     |                           |    |
| Pharmacogenetics                              | Clock                  |           |             |      |     |       |       |     |                           |    |
| (tanL or 1 top of blood)                      | pe                     |           |             |      |     |       |       |     |                           |    |
| infining                                      | Page 12 of 29          |           |             |      |     |       |       |     |                           |    |  
Y  Department of Veterans Affairs  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:  
  
  
* For post-menopausal women 55 years old or younger, a serim pregnancy lest including Follicle-stimulating hormone (FSR) levels will be collected at screening.  If
Category coufirmed post-menopausal at screening, no additional pregnancy testing is required. For women of chid-bearing potential, urine pregnancy tests will be performed at Day 1 of each cycle, End of Treatment Visit, and PTFU until 6 months after the last dose of blinded investigational product.  
*These samples may not be performed. Your doctor will let you know, Table Abbreviations: NTC-Non-Treatment Cycle; PTFU-Post-Treatment Follow up; q-every; SAE=Serious Adverse Events; C=cycle  
  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
Clinical trial: NCT03033511
Section: Purpose of Research
Subsections: Purpose Of Research

You are invited to participate in a research study of an investigational drug called Rovalpituzumab Tesirine (Rova-T) in subjects with Small Cell Lung Cancer (SCLC).  An investigational drug is one that has not been approved by the regulatory authorities in your country. The purpose of this study is to: learn if the drug called rovalpituzumab tesirine taken after platinum-based chemotherapy will prolong the time your cancer is not getting worse; evaluate the safety and tolerability of rovalpituzumab tesirine; and understand why some subjects respond or experience side effects while others do not, despite receiving the same treatment.  
Rovalpituzumab tesirine is a type of drug called an antibody drug conjugate or ADC.  ADCs usually have 2 parts:  a part that targets tumor cells (the antibody)
and a cell-killing part (the toxin).  Antibodies are proteins that are part of your immune system.  They can stick to and attack specific targets on cells.  
If you decide to be in the study, you will be randomly assigned (like flipping a coin)
to one of two groups.  You will either receive rovalpituzumab tesirine and dexamethasone, or you will receive placebos (a placebo is a dummy medication that looks like the real medication but has no active ingredients). Neither you nor your study doctor will be able to pick if you receive rovalpituzumab tesirine and dexamethasone, or if you receive the placebos.  You will have an equal chance of being in either study group.  This is a double-blinded study, which means neither you nor your study doctor will know to which study group you were assigned.  In case of an emergency, your study doctor can find out this information.  
This research study is looking for approximately []] people with small cell lung cancer (SCLC) at approximately […] research centers worldwide.  The
� expects to enroll up to� research study subjects. If the target number of subjects has been enrolled, and you are in screening, there is a possibility that you will not be enrolled.  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:  
| VAMC:   |
|---------|
Clinical trial: NCT03033511
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this study is entirely voluntary.  Your decision not to participate will not have any negative effect on you or your medical care.  You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care you are entitled to.
Clinical trial: NCT03033511
Section: Withdrawal from Study
Subsections: Withdrawal From Study

If you first agree to participate and then you change your mind, you are free to withdraw your consent and stop your participation at any time.  If you decide to withdraw from the study, you will not lose any benefits to which you would otherwise be entitled and your decision will not affect your ability to receive medical care for your condition.  
If you want to stop being in the study you should tell the investigators or study staff.  You can do this by phone by calling the principal investigator,
, or by calling the study coordinator at You may withdraw from the main study and optional research at any time and may request that your samples be withdrawn at any time by notifying the study doctor in writing. There will be no consequences or penalties if you do this. If you withdraw from the main study, your samples will continue to be stored and analyzed for exploratory research as described in this form unless you specifically withdraw from the optional research.   Once AbbVie is notified that you have changed your mind about the optional research, no new research will be started, and your samples will be destroyed unless the FDA requires the sponsor to keep the samples. However, data and results that are generated from testing on your samples before the sponsor is notified will still be used.  
  
Expiration Date:  
Title of Study:  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
Title of Consent (if different from Study Title):
Principal Investigator:
The study may be stopped early by AbbVie, the investigator, the IRB or the FDA.  
You could be withdrawn from the study without your consent, at any time and for any reason. These include, but are not limited to, the following:
ooo Failure to follow the instructions of the investigators and/or study staff.  
The investigators decide that continuing your participation o could be harmful to you.  
Pregnancy (if applicable).  
o You need treatment not allowed in the study.  
o The study is cancelled.  
o Other administrative reasons.  
o Unanticipated circumstances.  
o