Clinical trial NCT03574753
Conditions: Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC V7
Sponsor: SWOG Cancer Research Network
Start date: 2018-03-16; Completion date: 2021-07-30
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA.

S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.

Detailed description:

Arms: arm 1: C-MET overexpression is seen in 30% of patients with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.

ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.
Interventions: intervention 1: ABBV-399
Intervention descriptions: intervention 1: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days

Protocol documents:
Prot_SAP_000.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400K, “A Phase II Study of ABBV-399 (Process II) in Patients with c-Met Positive Stage 
IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-Study)” 
 
 
NCT Number: 03574753 
 
 
Version Date: 10/21/20 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400K [NCT 03574753].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400K is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 















































































































































ICF_001.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400K, “A Phase II Study of ABBV-399 (Process II) in Patients with c-Met Positive Stage 
IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-Study)” 
 
 
NCT Number: 03574753 
 
 
Version Date: 10/21/20 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400K [NCT 03574753].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400K is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


Readability Statistics:   
S1400K 
Flesch Reading Ease 61.5 
Treatment Consent 
Flesch-Kincaid Grade Level 8.9 
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Study Title for Study Participants:  Targeted Treatment for 
Advanced Squamous Cell Lung Cancer 
 
Official Study Title for Internet Search on 
http://www.ClinicalTrials.gov:  
S1400, “A Biomarker-Driven Master Protocol for Previously Treated 
Squamous Cell Lung Cancer” 
 
S1400K, “A Phase II Study of ABBV-399 (Process II) in Patients with 
c-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer 
(Lung-MAP Sub-Study)” 
 
What is the usual approach to my lung cancer? 
Squamous cell lung cancers make up about one-fourth of non-small cell lung cancer. Various 
chemotherapy drugs have been shown to improve survival for patients with advanced squamous 
cell lung cancer. Most patients, for example, will be treated at first with a platinum-based 
chemotherapy (like cisplatin or carboplatin) in combination with a second chemotherapy drug 
such as gemcitabine, paclitaxel, docetaxel, or vinorelbine.   
 
In addition, immunotherapy has been FDA approved for patients whose disease has gotten 
worse. The approval was based on results of clinical trials where patients had improved overall 
survival with immunotherapy compared to standard chemotherapy. 
• For patients with previously untreated squamous cell lung cancer, immunotherapy 
options include pembrolizumab alone for tumors that have a high expression of a marker 
called PD-L1. 
• For patients whose disease has gotten worse while receiving platinum-based 
chemotherapy (like cisplatin or carboplatin), immunotherapy options include 
pembrolizumab alone for tumors with a low tumor expression of PD-L1.   
• Other available immunotherapy options are nivolumab and atezolizumab, which do not 
need PD-L1 expression testing. 
 
What are my other choices if I do not take part in this study? 
Your other choices may include: 
• You may choose to have the usual approach described above 
• You may choose to take part in a different study, if one is available 
• You may choose to get 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, but instead tries to improve how you feel.  Comfort care 
tries to keep you as active and comfortable as possible.   
 


 
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Why is this study being done? 
There are several investigational treatments that are being tested in various sub-studies as part of 
this study.  You will have already received the information on your biomarker testing.  You have 
been assigned to this treatment study because your tumor sample is c-MET positive.  C-MET is a 
protein that is involved in tumor growth and exists on the surface of lung cancer cells.  For this 
sub-study, you will be assigned to treatment with a drug called ABBV-399 (Process II).  ABBV-
399 (Process II) is considered investigational, which means that it has not been approved by the 
U.S. Food and Drug Administration (FDA). ABBV-399 (Process II) is a type of drug called an 
antibody-drug conjugate (ADC).  ADC’s are designed to more precisely deliver chemotherapy to 
cancer cells and spare healthy cells.  ABBV-399 (Process II) binds to the protein c-MET that is 
expressed on the surface of lung cancer cells. After binding, the ADC enters the cell and 
separates the chemotherapy from the antibody so that it becomes active. The purpose of this sub-
study is to test the safety of ABBV-399 (Process II) and find out what effects, if any, ABBV-399 
(Process II) has on people and their lung cancer.  ABBV-399 (Process II) may or may not shrink 
your cancer and it could also cause side effects. 
 
There will be about 44 patients taking part in this sub-study. 
 
What are the study groups? 
You have been assigned to this sub-study because your tumor sample is c-MET positive.   
 
All patients will receive the study drug ABBV-399 (Process II). The study drug will be given 
through a vein in your body over about 30 minutes on Day 1 of every 21-day cycle.  
 
The treatment on this study is described in the table below: 
 
Drug 
How often is it 
given? 
How is it 
given? 
What days is it 
given on? 
How long is the 
cycle? 
ABBV-399 
(Process II) 
Once per cycle 
every 21 days 
Into a vein 
Day 1 
21 days 
 
 
 


 
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Another way to find out what may happen to you during the study is to read the chart below.  
Start reading at the top of the chart and read down, following the arrows. 
 
 
Screening/Pre-Screening Registration 
 
 
Genetic testing of your tumor sample 
 
 
c-MET Positive 
 
 
S1400K 
 
 
ABBV-399 (Process II) 
 
How long will I be in this study? 
You will receive treatment until your disease worsens, you experience a severe side effect, or 
your doctor thinks you should stop taking the study treatment. After you are finished taking 
study treatment, the study doctor will continue to watch you for side effects and follow your 
condition for up to three years from the time you started treatment.  At the follow up visits you 
will have a physical exam, blood tests, and scans.  Your doctor may give you other tests or 
procedures if they think they are needed for the regular care of your disease. 
 
Should your disease worsen, you have the option to participate in a different sub-study.  As 
before, the new sub-study that you will be offered will depend on a combination of the results of 
the previous testing done on your tumor sample and the sub-studies available. If the tests show 
that your tumor has more than one biomarker that qualifies you for a different sub-study, you 
will be assigned to one of these sub-studies randomly (by chance). A sub-study may be available 
if your tumor does not have any additional biomarkers being tested or you were not eligible to 
participate in other sub-studies.  
 
What extra tests and procedures will I have if I take part in this study? 
Most of the exams, tests, and procedures you will have are part of the usual approach for your 
cancer.  However, there are some extra exams, tests, and/or procedures that you will need to have 
if you take part in this study. 
 
The left-over tumor sample from your screening biomarker testing will have additional 
laboratory tests. The samples will be kept until there are no additional sub-studies for you to 
enroll in or they are used up, whichever happens first. If any tumor is left over after the 
laboratory studies and there are no additional sub-studies for you to enroll in, and if you agreed, 
it will be stored for biobanking. This was discussed in the screening consent section on optional 
studies. 
 


 
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If the exams, tests, and procedures show that you are eligible to take part in the study, and you 
choose to take part, then you will need the following extra tests.  They are not part of the usual 
approach for your type of cancer. 
 
Before you begin the study: 
o Brain CT or MRI (to check if your cancer may have spread to your brain) 
o Blood tests to assess your liver functions (GGT), kidney functions (phosphate and 
magnesium), and testosterone levels in men  
 
During the study: 
o Brain CT or MRI (to check if your cancer may have spread to your brain) 
o Blood tests to assess your liver functions (GGT), kidney functions (phosphate and 
magnesium), and testosterone levels in men 
o Blood tests for studies of drug levels 
 
Neither you nor your health care plan/insurance carrier will be billed for the following tests 
obtained for the purpose of this study. 
o Blood tests for studies of drug levels 
o Blood tests to assess your liver functions (GGT) kidney functions (phosphate and 
magnesium), and testosterone levels in men 
 
You might receive a CT or MRI even if you were not on the study as part of your usual cancer 
care. You will have a CT or MRI done before you begin the study and then approximately every 
six weeks for the first year then every 3 months until your disease worsens and stop treatment. 
Your doctor will review the CT scans or other radiographic scans done to check on your tumors 
on a regular basis.  These scans will also be sent to a central location for review.  This central 
review is part of a total study analysis only. Information on your scans from the central review 
will not be sent back to you or your doctor. 
 
The blood test to assess your liver and kidney functions and testosterone levels (males) will be 
done before you begin the study and at each cycle. Additional blood samples are also required 
for you to take part in this study.  
 
Researchers for this study are interested in testing what happens to the study drug once it gets in 
your body- this is called pharmacokinetic testing. The samples will be collected on Day 1 of 
Cycles 1, 2, 3, and 4. One sample will be collected 30 minutes before you start treatment and 
another sample will be collected about an hour after treatment. At each time point you will have 
a single needle stick and about 1 tablespoon of blood will be collected. 
 
 
 


 
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What possible risks can I expect from taking part in this study? 
If you choose to take part in this study, there is a risk that you may: 
• Lose time at work or home and spend more time in the hospital or doctor’s office than 
usual 
• Be asked sensitive or private questions which you normally do not discuss 
 
The treatment used in this study may affect how different parts of your body work such as your 
liver, kidneys, heart, and blood. The study doctor will be testing your blood and will let you 
know if changes occur that may affect your health. 
 
There is also a risk that you could have side effects. 
 
Here are important points about side effects: 
• The study doctors do not know who will or will not have side effects. 
• Some side effects may go away soon, some may last a long time, or some may never go 
away. 
• Some side effects may interfere with your ability to have children. 
• Some side effects may be serious and may even result in death. 
 
Here are important points about how you and the study doctor can make side effects less of a 
problem: 
• Tell the study doctor if you notice or feel anything different so they can see if you are 
having a side effect. 
• The study doctor may be able to treat some side effects. 
• The study doctor may adjust the study drug to try to reduce side effects. 
 
Your drug medication list will be reviewed at each visit.  You will be given a handout and wallet 
card about potential drug interactions.  Your study doctor will discuss with you of any potential 
drug interactions. 
 
The tables provided below show the most common and the most serious side effects that 
researchers know about related to ABBV-399 (Process II). There might be other side effects that 
researchers do not yet know about. If important new side effects are found, the study doctor will 
discuss these with you. 
 
 
 


 
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Possible Side Effects of ABBV-399 (Process II) 
 
COMMON, SOME MAY BE SERIOUS   
In 100 people receiving ABBV-399 (Process II), more than 20 and up to 100 may have:  
• Constipation 
• Nausea 
• Tiredness 
• Swelling of arms, legs 
 
OCCASIONAL, SOME MAY BE SERIOUS   
In 100 people receiving ABBV-399 (Process II), from 4 to 20 may have:  
• Anemia which may cause tiredness, or may require blood transfusion 
• Infection, especially when white blood cell count is low  
• Diarrhea 
• Vomiting 
• Loss of appetite 
• Pain in joints 
• Numbness, tingling or pain of the hands, arms, feet and legs 
• Low blood pressure which may cause feeling faint 
 
RARE, AND SERIOUS 
In 100 people receiving ABBV-399 (Process II), 3 or fewer may have: 
• Muscle weakness 
• Swelling in testis (males) 
 
Let your study doctor know of any questions you have about possible side effects. You can ask 
the study doctor questions about side effects at any time. 
 
Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study 
as the drugs used in this study could be very damaging to an unborn or newborn baby. There 
may be some risks that researchers do not yet know about.  It is very important that you check 
with your study doctor about what types of birth control or pregnancy prevention to use during 
the study and for 6 months after you have completed the study. 
 
Pneumonitis, a lung inflammation not due to an infection, is a known risk of cancer therapies you 
may have received.  Therapies such as: immunotherapy, kinase inhibitors, and a drug called 
ADCETRIS®.  ADCETRIS® is similar to ABBV-399.  It is not clear if ABBV-399 causes 
pneumonitis; however, pneumonitis (including some cases that have resulted in death), has been 
reported in patients receiving ABBV-399 in clinical trials. Your doctor may decide to delay, 
withhold, or discontinue ABBV-399 treatment if you and your doctor think it would be in your 
best interest. 
 


 
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What possible benefits can I expect from taking part in this study? 
It is not possible to know at this time if the study drug/study approach is better than the usual 
approach, so this study may or may not help you.  This study will help researchers learn things 
that will help people in the future. 
 
Can I stop taking part in this study? 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study doctor know as soon as possible so you can stop safely. If you stop, you can decide 
whether or not to let the study doctor continue to provide your medical information to the 
organization running the study. 
 
The study doctor will tell you about new information or changes in the study that may affect 
your health or your willingness to continue in the study. 
 
The study doctor may take you out of the study: 
• If your health changes and the study is no longer in your best interest 
• If new information becomes available 
• If you do not follow the study rules 
• If the study is stopped by the sponsor, IRB or FDA. 
 
What are my rights in this study? 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal 
rights. 
 
For questions about your rights while in this study, call the ________________________ 
(insert name of center) Institutional Review Board at __________________ (insert telephone 
number). (Note to Local Investigator: Contact information for patient representatives or other 
individuals at a local institution who are not on the IRB or research team but take calls 
regarding clinical trial questions can also be listed here.) 
 
What are the costs of taking part in this study? 
ABBV-399 (Process II) will be supplied at no charge while you take part in this study. The cost 
of getting ABBV-399 (Process II) ready and giving it to you is not paid by the study sponsor so 
you or your insurance company may have to pay for this. It is possible that ABBV-399 (Process 
II) may not continue to be supplied while you are on the study. Although not likely, if this 
occurs, your study doctor will talk to you about your options. 
 
You and/or your health plan/insurance company will need to pay for all of the other costs of 
treating your cancer while in this study, including the cost of tests, procedures, or medicines to 
manage any side effects, unless you are told that certain tests are supplied at no charge. Before 
you decide to be in the study, you should check with your health plan or insurance company to 
find out exactly what they will pay for. 
 
You will not be paid for taking part in this study. 


 
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What happens if I am injured or hurt because I took part in this study? 
If you are injured or hurt as a result of taking part in this study and need medical treatment, 
please tell your study doctor. The study sponsors will not offer to pay for medical treatment for 
injury. Your insurance company may not be willing to pay for study-related injury. If you have 
no insurance, you would be responsible for any costs. 
 
If you feel this injury was a result of medical error, you keep all your legal rights to receive 
payment for this even though you are in a study. 
 
Who will see my medical information? 
Your privacy is very important to us.  The study doctors will make every effort to protect it.  The 
study doctors have a privacy permit to help protect your records if there is a court 
case.  However, some of your medical information may be given out if required by law.  If this 
should happen, the study doctors will do their best to make sure that any information that goes 
out to others will not identify who you are.   Some of your health information, and/or 
information about your specimen, from this study will be kept in a central database for research. 
Your name or contact information will not be put in the database. 
 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private, unless required by law to provide information. Some of 
these organizations are: 
• The study sponsor, SWOG, and the drug company supporting the treatment sub-study 
you are on. 
• The Institutional Review Board, IRB, is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
• The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) in the 
U.S., and similar ones if other countries are involved in the study. 
• TRIAD-Your medical images with clinical study data (e.g., the treatment Group you are 
assigned to, etc.) will be transferred to the Ohio State University in Columbus, Ohio.  
Your medical images will be reviewed by physicians at this organization as part of the 
study analysis for this trial.  
• In addition, information gained from this study may be used in the future for additional 
research and only that data would be provided to other scientist for future research.  Your 
name, and any other information that could be used to identify you personally, will not be 
included. 
 
Where can I get more information? 
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to get 
the same information at: 1-800-4-CANCER (1-800-422-6237). 
 


 
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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. 
 
[Note to Informed Consent Authors:  The above paragraph complies with the new FDA 
regulation found at 21CFR50.25 (c) and must be included verbatim in all informed consent 
documents.  The text in this paragraph cannot be revised.] 
 
Who can answer my questions about this study? 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor __________________ (insert name of 
study doctor[s]) at __________________ (insert telephone number). 
 
This section is about optional studies you can choose to take part in 
This part of the consent form is about optional studies that you can choose to take part in. You 
will not get health benefits from any of these studies. The researchers leading this optional study 
hope the results will help other people with cancer in the future. 
 
The results will not be added to your medical records, nor will you or your study doctor know 
the results. 
 
You will not be billed for these optional studies. You can still take part in the main study even if 
you say ‘no’ to any or all of these studies. If you sign up for but cannot complete any of the 
studies for any reason, you can still take part in the main study. 
 
Circle your choice of “yes” or “no” for each of the following studies. 
 
1. Optional Additional Biopsy and Optional Sample Collections for 
Laboratory Studies and/or Biobanking for Possible Future Studies 
Researchers are trying to learn more about cancer, diabetes, and other health problems. Much 
of this research is done using samples from your tissue, blood, urine, or other fluids. Through 
these studies, researchers hope to find new ways to prevent, detect, treat, or cure health 
problems. 
 
Some of these studies may be about genes. Genes carry information about features that are 
found in you and in people who are related to you. Researchers are interested in the way that 
genes affect how your body responds to treatment. 
 
If you choose to take part in this part of the study, the researchers would also like to ask your 
permission to store and use your samples and health information for medical research. The 
research that may be done is unknown at this time. Storing samples for future studies is called 


 
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“biobanking”. The Biobank is being run by SWOG and supported by the National Cancer 
Institute. 
 
WHAT IS INVOLVED? 
If you agree to take part, here is what will happen next: 
1) 
Your specimens may be stored in the Biobank, along with samples from other 
people who take part.  These specimens may include: 
• About 2 tablespoons of blood will be collected from a vein in your arm (at 
the same time as other study blood tests) on Baseline, weeks 4, 7, 10, and 
again if your cancer gets worse.  
o The most common risks related to drawing blood from your arm are 
brief pain and possibly a bruise. 
• A sample of tissue will be collected from an optional extra biopsy if your 
cancer gets worse after treatment on this study.  Common side effects of a 
biopsy are a small amount of bleeding at the time of the procedure, pain 
and bruising at the biopsy site, which can be treated with regular pain 
medications. 
Rarely, an infection can occur. Rarely, patients may experience partial 
lung collapse that may require a chest tube or breathing machine. You will 
sign a separate consent form before the biopsy is taken. This will be a 
standard surgical consent form from the institution where the biopsy 
procedure takes place. The samples may be used to test for genes (DNA, 
RNA), protein or metabolites and will be kept until they are used up. 
2) 
Qualified researchers can submit a request to use the materials stored in the 
Biobanks. A science committee at the clinical trials organization, and/or the 
National Cancer Institute, will review each request. There will also be an ethics 
review to ensure that the request is necessary and proper. Researchers will not be 
given your name or any other information that could directly identify you.  
3) 
Neither you nor your study doctor will be notified when research will be 
conducted or given reports or other information about any research that is done 
using your samples.  
4) 
Some of your genetic and health information may be placed in central databases 
that may be public, along with information from many other people. Information 
that could directly identify you will not be included. 
 
WHAT ARE THE POSSIBLE RISKS? 
1) 
There is a risk that someone could get access to the personal information in your 
medical records or other information researchers have stored about you. 
2) 
There is a risk that someone could trace the information in a central database back 
to you. Even without your name or other identifiers, your genetic information is 
unique to you. The researchers believe the chance that someone will identify you 
is very small, but the risk may change in the future as people come up with new 
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3) 
In some cases, this information could be used to make it harder for you to get or 
keep a job or insurance. There are laws against the misuse of genetic information, 
but they may not give full protection. There can also be a risk in knowing genetic 
information.  There are laws against misuse of genetic information, but they may 
not give full protection. The Genetic Information Nondiscrimination Act of 2008, 
also referred to as GINA, was passed by Congress to protect Americans from such 
discrimination. The law prevents discrimination from health insurers and 
employers. This law does not cover life insurance, disability insurance and long-
term care insurance.  New health information about inherited traits that might 
affect you or your blood relatives could be found during a study. The researchers 
believe the chance these things will happen is very small, but cannot promise that 
they will not occur. 
 
HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE? 
Your privacy is very important to the researchers and they will make every effort to protect it. 
Here are just a few of the steps they will take: 
 
1) 
When your samples are sent to the researchers, no information identifying you 
(such as your name) will be sent. Samples will be identified by a unique code 
only.  
2) 
The list that links the unique code to your name will be kept separate from your 
sample and health information. Any Biobank and SWOG staff with access to the 
list must sign an agreement to keep your identity confidential. 
3) 
Researchers to whom SWOG sends your sample and information will not know 
who you are. They must also sign an agreement that they will not try to find out 
who you are. 
4) 
Information that identifies you will not be given to anyone, unless required by 
law. 
5) 
If research results are published, your name and other personal information will 
not be used. 
 
WHAT ARE THE POSSIBLE BENEFITS? 
You will not benefit from taking part in this study.  
 
The researchers, using the samples from you and others, might make discoveries that could help 
people in the future. 
 
ARE THERE ANY COSTS OR PAYMENTS? 
Neither you nor your health care plan/insurance carrier will be billed for the collection or testing 
of the tumor tissue or blood samples that will be used for this study. You will not be paid for 
taking part. If any of the research leads to new tests, drugs, or other commercial products, you 
will not share in any profits. 
 


 
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WHAT IF I CHANGE MY MIND? 
If you decide you no longer want your samples to be used, you can call the study doctor, 
_________________, (insert name of study doctor for main trial) at 
________________________ (insert telephone number of study doctor for main trial) who will 
let the researchers know. Then, any sample that remains in the bank will no longer be used. 
 
Samples or related information that have already been given to or used by researchers will not be 
returned. 
 
WHAT IF I HAVE MORE QUESTIONS? 
If you have questions about the use of your samples for research, contact the study doctor, 
________________, (insert name of study doctor for main trial), at _____________________ 
(insert telephone number of study doctor for main trial). 
 
 
SAMPLES FOR FUTURE RESEARCH STUDIES:  
Please circle your answer to show whether or not you would like to take part in each option 
(include only applicable questions): 
 
1. 
If my cancer responds to treatment on this study, and then gets worse, I agree to 
have an optional biopsy to collect a sample of tissue.  I agree to have this tumor 
tissue and related information kept in a Biobank for use in future health research. 
 
YES 
 
NO 
 
2. 
My blood samples and related information may be kept in a Biobank for use in 
future health research. 
 
YES 
 
NO 
 
This is the end of the section about optional studies. 
 
 
My Signature Agreeing to Take Part in the Main Study 
 
I have read this consent form, or had it read to me. I have discussed it with the study doctor and 
my questions have been answered. I will be given a signed copy of this form. I agree to take part 
in the main study and any additional studies where I circled ‘yes’.  
 
Participant’s signature  
 
 
Date of signature