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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study

Date Added
May 6th, 2021
PRO Number
Pro00109905
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of the study drug, brensocatib, as treatment for NCFBE. This is a double-blinded study.
The maximum study duration is 62 weeks total for an individual participant, including a Screening Period of up to 6 weeks, a Treatment Period of 52 weeks, and an End-of-Study Visit 4 weeks following the end of treatment. Approximately 1,620 subjects between the ages of 18 and 85 years, with diagnosed NCFBE are expected to participate in this study. The study is being conducted at approximately 480 centers in North America, Europe, Japan, and the rest of the world. All subjects will complete the same study procedures. The study will last approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There will be 12 visits including the Screening Visit (1 visit), Study Treatment Visits (10 visits: 6 visits are in the study clinic [Visits 2, 3, 5, 7, 9, and 11], and 4 visits by telephone from your home [Visits 4, 6, 8, and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit 12) will occur in the study clinic.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
(843) 792-3162
chambeam@musc.edu

COVID-19: A Mulicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19

Date Added
April 8th, 2021
PRO Number
Pro00109695
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Drug Studies, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@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

Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

Date Added
March 3rd, 2021
PRO Number
Pro00108490
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with Metastatic EGFR-Mutant Lung Cancer. The purpose of this study is to compare the usual treatment of AZD9291 (osimertinib) alone to using bevacizumab plus AZD9291 (osimertinib). The drug, AZD9291 (osimertinib), is already approved by the FDA for use by itself to treat lung cancer. The drug, bevacizumab, is also already approved by the FDA when given with chemotherapy for treatment of advanced lung cancer. The addition of bevacizumab to other EGFR-targeting drugs has shown promise by delaying the time until progression on treatment for patients with EGFR-mutant lung cancers. Participants can expect to be on this study until their cancer returns or spreads, or the participant experiences unacceptable side effects, or until they decide to come off study. Participants will then be followed for 10 years after the date they enrolled to the study.

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

A PHASE 1B/2A, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF AP-PA02 MULTI-PHAGE THERAPEUTIC CANDIDATE FOR INHALATION IN SUBJECTS WITH CYSTIC FIBROSIS AND CHRONIC PULMONARY PSEUDOMONAS AERUGINOSA (PA) INFECTION

Date Added
February 23rd, 2021
PRO Number
Pro00104908
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

Armata Pharmaceuticals, Inc. (Armata) has begun a study of an investigational drug (also known as the "study drug") called AP-PA02 as a possible treatment for individuals with cystic fibrosis (CF) and chronic pulmonary Pseudomonas aeruginosa (Pa) infection. The main purposes of this study are to learn about how safe and how well tolerated the study drug is compared to the placebo. This study has two parts, Part 1 and Part 2. You may only participate in Part 1 or Part 2, not both. If you participate in Part 1 of the study, the screening period is up to 21 days, and the on-study period is 29 days, for a total of up to 50 days, and you will need to come to the study center 8 times over this study period. If you are in Part 2 of the study, the screening period is up to 21 days, and the on-study period is 31 days, for a total of up to 52 days, and you will need to come to the study center 10 times over this study period. This study will take place in approximately 12 centers in the United States with about 48 people with CF and chronic Pa participating.

Institution
MUSC
Recruitment Contact
Angel Darrow
(843) 792-8092
darrowa@musc.edu

Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma

Date Added
February 17th, 2021
PRO Number
Pro00105498
Researcher
John Cox

List of Studies


Keywords
Asthma, Lung, Pulmonary
Summary

The purpose of the study is to help doctors learn more about investigational dupilumab (the study drug) and to find out how safe it is and how well it works for patients with asthma. The study will investigate whether the study drug can help to improve the health of your lungs, reduce the inflammation in your airways and also improve your quality of life. If you join the study, your participation will last a minimum of 29 weeks and up to 41 weeks and is planned to include approximately 153 participants. The study will be conducted worldwide. If the study is suited for you, you will be randomized by chance (like drawing straws) to receive either the study drug (300 mg dupilumab) or placebo.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
(843) 792-3162
chambeam@musc.edu

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Date Added
February 8th, 2021
PRO Number
Pro00107771
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

This is a randomized, double-blind, placebo-controlled, active comparator study in eligible subjects with a new diagnosis of MAC lung infection. The purpose of this study is to validate a patient-reported outcomes questionnaire in newly diagnosed subjects given amikacin liposome inhalation suspension (ALIS) as part of a study treatment regimen for NTM caused by MAC. This study will also evaluate the safety and efficacy of the study treatments with ALIS inhalation therapy, azithromycin (AZI) and ethambutol (ETH). Around 100 subjects 18 years and above of age with newly diagnosed NTM caused by MAC are expected to participate in this study. The study will last around 9.5 months from the Screening visit to the end of the study.

Institution
MUSC
Recruitment Contact
Grant Allen
(843) 792-3900
allengr@musc.edu



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