A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

Date Added
July 27th, 2020
PRO Number
Pro00100716
Researcher
John Wrangle

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-squamous non-small cell lung cancer. The purpose of this study is to evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with Stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. The investigational drugs used in this study are talazoparib and avelumab. Talazoparib and avelumab are drugs that may increase the ability of your immune system to fight lung cancer. Participants can expect to be on this study until disease progression, the side effects come to severe or they choose to discontinue the study. Participants will be followed by the study doctor for up to 3 years.

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

An Observational Long-Term Safety Surveillance Study Of Participants From Corbus Sponsored Lenabasum Pivotal Clinical Trials

Date Added
July 15th, 2020
PRO Number
Pro00101371
Researcher
Patrick Flume

List of Studies

Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This observational research study will collect safety information from subjects who received study treatment (lenabasum or placebo) in a Corbus-sponsored pivotal clinical trial. This is being done to understand how stopping the study treatment affects the subject, and to make sure that the subject is not experiencing any side effects from stopping the study treatment. The subject will not be given any investigational drugs, including lenabasum or a placebo, in this study. The subject will be assessed (by telephone or office visit) approximately every 6 months for up to 2 years from the time of the last safety visit in a pivotal trial, unless Corbus stops studying lenabasum or decides to stop the study itself. The number of potential phone calls will depend on when the subject joins the study, but will not exceed 5 total. Approximately 100 subjects are expected to take part in this study in North America, Europe, and Asia-Pacific (APAC).

Institution
MUSC
Recruitment Contact
Nadine O'Connor
(843) 792-6890
oconnorn@musc.edu

A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Date Added
July 7th, 2020
PRO Number
Pro00100686
Researcher
John Wrangle

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have RET Fusion-Positive Stave IV or Recurrent Non-Small Cell Lung Cancer. The purpose of this study is to see if we can lower the chance of RET Fusion-Positive Advanced Non-Small Cell Lung Cancer growing or spreading by using the study drug selpercatinib (LOXO-292). Selpercatinib (LOXO-292) is a drug that inhibits RET, a biomarker present in your tumor. Participants will be on this study until disease progression, the side effects become too severe or until they choose to discontinue the study. Participants will be followed by the study doctor for up to 3 years.

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

A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Date Added
July 7th, 2020
PRO Number
Pro00100647
Researcher
John Wrangle

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer that has spread outside of the lungs, and the tumor sample has a biomarker which is positive for LOH (loss of heterozygosity) or BRCA1/2 mutations. The purpose of this study is to test the good and bad effects of the study drug, rucaparib. Rucaparib is a drug that works by slowing or stopping the growth of cancer cells. Patients can expect to be on this study until disease progression or until the side effects become too severe. Patients will then be followed by their study doctor for up to 3 years after study completion.

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

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Date Added
July 7th, 2020
PRO Number
Pro00100627
Researcher
John Wrangle

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. The purpose of this study is to compare the usual treatment (standard of care) to using ramucirumab plus pembrolizumab (study drug). Patients can expect to be on this study until disease progression or until the side effects become too severe. Patients will then be followed by their study doctor for up to 3 years after study completion.

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

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET trial)

Date Added
July 6th, 2020
PRO Number
Pro00097400
Researcher
Nicholas Pastis

List of Studies

Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

Physicians currently have difficulty getting a biopsy of lung spots that are far from the center of the lung. The bronchoscopes that are currently used to reach these spots are sometimes difficult to maneuver and are unable to reach these spots. This study will test the performance of a new robotic bronchoscope that uses navigation software to find the distant spots in the lung so physicians can successfully get a biopsy.

Institution
MUSC
Recruitment Contact
Abby Wenzel
843-792-8233
goodsona@musc.edu

A PHASE III, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF REMDESIVIR PLUS TOCILIZUMAB COMPARED WITH REMDESIVIR PLUS PLACEBO IN HOSPITALIZED PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Date Added
June 29th, 2020
PRO Number
Pro00101225
Researcher
Nandita Nadig

List of Studies

Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of study treatment with remdesivir plus tocilizumab compared with remdesivir by itself on subjects with severe COVID19 pneumonia. In this study, the subject will receive standard supportive care treatment for COVID-19 pneumonia as well as remdesivir, and will additionally receive either tocilizumab, or placebo. About 450 people will take part in this study. Depending on the early results of the study, the total number of people who will take part may be increased to up to 800.

Institution
MUSC
Recruitment Contact
Abigail Grady
(843) 792-2072
gradyabi@musc.edu

Prospective Phase 0 Study to Investigate Pseudomonas aeruginosa and Staphylococcus aureus Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis

Date Added
June 25th, 2020
PRO Number
Pro00100720
Researcher
Patrick Flume

List of Studies

Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to collect phlegm and blood to learn more about the presence of bacteria in patients with Cystic Fibrosis (CF) or Non-Cystic Fibrosis Bronchiectasis (NCFB). This exploratory research study does not involve the administration of any medication. There are approximately 4 visits (1 visit to see for subject eligibility, and 3 visits during the study) to complete the study participation. The study will take two months. About 100 subjects will take part study-wide.

Institution
MUSC
Recruitment Contact
Angela Millare
(843) 792-3710
millare@musc.edu

Personalized Lung Cancer Screening (PLuS) Study

Date Added
May 14th, 2020
PRO Number
Pro00098558
Researcher
Gerard Silvestri

List of Studies

Keywords
Cancer, Lung
Summary

This is an observational study that will analyze electronic health records data from real-world populations and settings in order to fully characterize the outcomes of Lung Cancer Screening with Low-Dowse CT scans.

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

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Date Added
May 12th, 2020
PRO Number
Pro00096200
Researcher
Tatsiana Beiko

List of Studies

Keywords
Lung, Pulmonary
Summary

Benralizumab is a drug that can potentially reduce the number of exacerbations (attacks of restricted breathing) for people with chronic obstructive pulmonary disease (COPD). Benralizumab is given as an injection under the skin. Eligible participants will have a 50% chance of being placed in the treatment group (Benralizumab 100mg/mL) or a placebo (inactive substance). The study is double blind so neither the treatment team nor the participant will know what treatment they received. The study will take place for a minimum of one year, but can last up to three years. The study will officially end when every participant has completed one year of treatment.

Institution
MUSC
Recruitment Contact
Rachel Millan
8437920260
rmillan@musc.edu



-- OR --