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 BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, 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 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 BA3011 by intravenous (IV) infusion. The purpose of this study is to understand how BA3011 works with and without nivolumab in fighting cancer cells; to see what side effects BA3011 has when given alone and in combination with nivolumab; to understand how the body absorbs and processes BA3011; and to understand whether BA3011, 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

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination With Nivolumab In Patients With Advanced Solid Tumors

Date Added
October 12th, 2021
PRO Number
Pro00114862
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. The investigational drug in this study is BA3021. 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 BA3021 by intravenous (IV) infusion. The purpose of this study is to see how BA3021 alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe BA3021 is alone and in combination with nivolumab; to understand how the body absorbs and processes BA3011; to understand whether BA3011, 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) which may prevent the study drug from working and/or increase your risk of side effects. Participants can expect up to 75 clinic visits over a period of about 3 years.

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

Detecting cancers Earlier Through Elective plasma-based CancerSEEK Testing – Ascertaining Serial Cancer patients to Enable New Diagnostic II (DETECT-ASCEND 2)

Date Added
September 1st, 2021
PRO Number
Pro00110309
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

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

Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases From Small Cell Lung Cancer

Date Added
June 23rd, 2021
PRO Number
Pro00110550
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer, Cancer/Brain, Cancer/Lung
Summary

This study is for participants that have been diagnosed with small cell lung cancer, that has spread to the brain. The purpose of this study is to see if high dose radiation therapy delivered only to the small areas of brain cancer and avoiding the surrounding normal brain tissue, called stereotactic radiosurgery (SRS), decrease side effects related to memory and thinking compared to radiation to the entire brain, called, whole-brain radiation therapy (WBRT) that avoids the hippocampus but treats all of the brain tissue along with a drug that helps preserve memory and thinking called memantine. Participants can expect to be on this study for up to 6 months, depending on what treatment they receive (SRS alone or HA-WBRT with memantine). Participants will then be followed every 2 to 3 months for at least 1 year after study completion and then every 6 months for their lifetime or until disease progression.

Institution
MUSC
Recruitment Contact
Lydia Moats, Research Coordinator
864-725-7125
lydia.moats@selfregional.org

Adequacy for molecular analysis in EBUS-TBNA specimens vs. liquid biopsies in patients with NSCLC, aka, "The Liquid Trial"

Date Added
June 16th, 2021
PRO Number
Pro00105097
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study will be looking at biopsies taken from mediastinal lymph nodes and a blood sample from patients who have known or suspected metastatic lung cancer. These two samples will be compared using next-gen sequencing to explore if either sampling method offers better results.

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

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction

Date Added
June 14th, 2021
PRO Number
Pro00109559
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

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

Optimization and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Screening

Date Added
June 7th, 2021
PRO Number
Pro00110429
Researcher
Nichole Tanner

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study aims to create a test that will detect changes in the genes found in the patient's blood very soon after he/she develops lung cancer. Detecting lung cancer at an early stage can significantly reduce the chance that the patient will die from lung cancer. This test is expected to perform better than any other tests that are currently available.

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

A Phase II Study of Sotorasib (AMG 510) in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

Date Added
June 2nd, 2021
PRO Number
Pro00110695
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed and previously treated stage IV or recurrent KRAS G12C mutated non-squamous non-small cell lung cancer. The purpose of this study is to see if we lower the chance of the growth or spread of KRASG12C-mutated advanced non-squamous non-small cell lung cancer by using the study drug AMG 510. 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

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Date Added
March 3rd, 2021
PRO Number
Pro00108563
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.

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



-- OR --