A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

Date Added
September 8th, 2021
PRO Number
Pro00114065
Researcher
Timothy Whelan

List of Studies


Keywords
Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of PRM-151 versus placebo on patients with IPF during a 52-week period.. This study is testing an experimental drug called recombinant human pentraxin-2 (rhPTX-2; also known as PRM-151 or RO7490677). About 658 people will take part in this study.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteall@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

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

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



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