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 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 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 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

Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)

Date Added
April 1st, 2021
PRO Number
Pro00108004
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to treat patients with a drug called MK-3475 (pembrolizumab) with or without chemotherapy. Participants can expect to be on this study for up to 5 years.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

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

A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Date Added
November 3rd, 2020
PRO Number
Pro00104644
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This study is for patients that have been diagnosed with Non-Squamous Non-Small-Cell Lung Carcinoma (NSCLC). The purpose of this study is to compare the two investigational treatments (cabozantinib alone to using cabozantinib plus the usual treatment nivolumab) to the current standard of care second line therapy. The study drugs involved are cabozanitib alone and cabozantinib plus nivolumab. Participants can expect to be on this study for up to 3 years.

Institution
MUSC
Recruitment Contact
Amanda Kelley, RN
864-725-7125
amanda.kelley@selfregional.org



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