A Randomized Phase II Study of Carboplatin and Pemetrexed With Or Without Selpercatinib (LY3527723) In Patients With Non-Squamous RET Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease On Prior RET Directed Therapy (Lung-MAP Sub-Study)

Date Added
January 26th, 2023
PRO Number
Pro00125663
Researcher
John Wrangle

List of Studies


Keywords
Cancer/Lung
Summary

This study is for patients with RET-Positive advanced non-small cell lung cancer. The study is being done to see if by using the drug selpercatinib in combination with chemotherapy will lower the chances of this cancer of growing or spreading.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Mental Fatigue and Self-Care in Informal Oncology Caregivers: A Descriptive Mixed Methods Study

Date Added
October 7th, 2022
PRO Number
Pro00122174
Researcher
Megan Wayne

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Mental Health, Non-interventional
Summary

This study is for anyone 18 years or older who provides unpaid care for a loved one living with cancer outside of the hospital setting. The purpose of this study is to help future caregivers and patients by learning how mental fatigue affects caregivers of persons living with cancer and determine if mental fatigue, participating in self-care activities, and general caregiver quality of life are related. Informal caregivers will be invited to complete a confidential, online survey that takes between 25 and 35 minutes to finish. Caregivers who complete the survey may be contacted and asked to participate in a 45-60 minute follow up interview either online or via phone if they are interested. The results of this study will help guide future research to identify ways healthcare professionals can help caregivers handle the stresses of caregiving and provide the best care possible to their loved ones at home.

Institution
MUSC
Recruitment Contact
Megan Wayne
8433070366
wayneme@musc.edu

Neuroendocrine Tumors Patient Reported Outcomes (NET-PRO)

Date Added
August 23rd, 2022
PRO Number
Pro00120896
Researcher
William Lancaster

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Lung
Summary

The purpose of this research study is to gain patient feedback around their Neuroendocrine tumor (NET) diagnosis, including symptoms and quality of life with different NET treatments, factors that influence the order of treatments given, and how the order of NET treatments affect patient's quality of life, symptoms and survival. The main eligibility criteria for this study are being 18 or older and receiving the diagnosis of a neuroendocrine tumor on or after January 1st, 2019. Participation will last about 18 months, involving the completion of four electronic or paper surveys spaced six months apart. The first survey will take about 40 minutes to complete, while the other three surveys may take about 20 minutes each to complete. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Eryn Beal
(843) 792-7011
bealery@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Date Added
July 1st, 2022
PRO Number
Pro00120871
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with Stage IV or Recurrent Non-small cell lung cancer previously treated with Anti-PD-1 or Anti-PD-L1 therapy. The purpose of this study is to compare the usual treatments to using N-803 (ALT-803) plus pembrolizumab. N-803 (ALT-803) is an experimental drug that may activate someone's natural killer cells so that they can stimulate an immune response to help fight cancer. Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. This immunotherapy drug combination, N-803 (ALT-803) plus pembrolizumab, is not approved by the FDA for use in advanced lung cancer. Participants can expect to be on this study until disease progression, the side effects become too severe, or the participant decides to discontinue the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

CASCADE-LUNG: Cancer Screening Assay using DELFI; A Clinical Validation Study in Lung

Date Added
May 23rd, 2022
PRO Number
Pro00119559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

The purpose of this study is to collect blood samples to determine the ability of a blood-based test that can be used able to identify lung cancers that may or may not also be seen on images of lungs.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Translational Research Center in Lung Cancer Disparities (TRACER) Biospecimen/Pathology Core

Date Added
April 12th, 2022
PRO Number
Pro00119496
Researcher
Steven Carroll

List of Studies


Keywords
Cancer, Cancer/Lung, Men's Health, Minorities, Women's Health
Summary

This is study involves a research repository which is a collection of biospecimens and information about people who have various diseases or conditions, or who receive various treatments. This research repository is being created to make sure samples are available for research on how disparities may put people at greater risk for lung cancer. People who identify as Black, African American, African, Afro and Caribbean, as well as Native Peoples and LatinX individuals with African Ancestry are at increased risk for dying from lung cancer; people who live near highways, regardless of their race or ethnicity are at risk for getting lung cancer and dying, even if they do not smoke. In this study, researchers are asking to collect and store participants' biospecimens and health information. Biospecimens are samples of human material such as urine, blood, tissue, cells, DNA, RNA, and protein. Information is defined as health and/or other health-related information (such as survey answers, etc.) associated with a condition or treatment. Participants will have their information stored in a secure database and shared with other researchers for future research studies.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

DNA EVALUATION OF FRAGMENTS FOR EARLY INTERCEPTION - LUNG CANCER TRAINING STUDY (DELFI-L101 STUDY)

Date Added
March 1st, 2022
PRO Number
Pro00116049
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this study is to collect blood samples to determine if a blood-based test can be used to identify lung cancers that may or may not also be seen on images of lungs. Additionally, the study aims to see if a blood-based test can identify other types of cancers and health conditions.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination with AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

Date Added
January 11th, 2022
PRO Number
Pro00115977
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with small cell lung cancer (SCLC). The investigational drugs in the study are AMG 757 and AMG 404. Both drugs are immunotherapy treatments, medicines that work with your immune system to help fight cancer. AMG 757 and AMG 404 will be given together in a liquid form directly into participants' veins (intravenously). This study is being done to find out about the safety and efficacy (effects good or bad) of AMG 757 in combination with AMG 404 for the treatment of SCLC. Participants can expect to receive treatment for about 24 months.
The duration of AMG 757 and AMG 404 treatment will depend on how the disease responds to the investigational drugs and how the body tolerates AMG 757 and AMG 404. So, participation may be longer or shorter than this window. The study period includes screening period lasting up to 21 days, a treatment period, a first safety follow-up visit, and a second safety follow-up visit. This will be followed by long-term follow-up visits up to 1 year from the first dose of AMG 757 for a total of about 3 years in the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu



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