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

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 12 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 2 years in the study.

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

A PHASE 1B TRIAL OF TARLOXOTINIB AND SOTORASIB IN PATIENTS WITH KRAS G12C MUTATIONS

Date Added
November 23rd, 2021
PRO Number
Pro00115901
Researcher
Mariam Alexander

List of Studies

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

This study is for subjects that have been diagnosed with lung cancer. The purpose of the study is to determine the safety and effectiveness of 2 study drugs used in combination, for the treatment of your cancer. The drugs are named tarloxotinib and sotorasib. The Food and Drug Administration (FDA) has approved sotorasib for treatment of your type of lung cancer. Tarloxotinib is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 9-12 months, with routine visits occurring at MUSC.

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

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients with MET Overexpressing Advanced .Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00115889
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 advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.

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

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Date Added
October 26th, 2021
PRO Number
Pro00114229
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 non-small cell lung cancer (NSCLC). The investigational drug in this study is sotorasib. Investigational means it is not approved by the United States Food and Drug Administration (US FDA). Sotorasib is an anti cancer drug that is being developed for tumors with a specific mutation called Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C. The purpose of this study is to find out if sotorasib has any anti-tumor effect and how safe (including side effects) it is in subjects with stage 4 NSCLC with a KRASG12C mutation. This drug is a tablet taken by mouth once a day. Participants can expect to receive treatment approximately 6 to 12 months including about 48 clinic visits followed by 5 years of follow-up.

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

A Phase 2 Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on or Are Intolerant to a PD-1/L-1, EGFR, or ALK Inhibitor

Date Added
October 12th, 2021
PRO Number
Pro00113721
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 metastatic Non-Small Cell Lung Cancer (NSCLC). The investigational drug in this study is Mecbotamab Vedotin (BA3011). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Mecbotamab Vedotin by intravenous (IV) infusion. The purpose of this study is to understand how Mecbotamab Vedotin works with and without nivolumab in fighting cancer cells; to see what side effects Mecbotamab Vedotin has when given alone and in combination with nivolumab; to understand how the body absorbs and processes Mecbotamab Vedotin; and to understand whether Mecbotamab Vedotin, alone or in combination with nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body). Participants can expect to be in this study for about 2 and a half years.

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



-- OR --