A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

Date Added
November 5th, 2020
PRO Number
Pro00098515
Researcher
Nichole Tanner

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research is to evaluate if including the investigational Nodify XL2 test results in the decision-making process when planning the management of lung nodules will reduce the number of unnecessary surgical and biopsy procedures. The general study procedures include obtaining blood samples for Nodify XL2 tests, collecting relevant medical information (including test results ordered by your doctor in the management of your lung nodule), and documenting your doctor's recommendations for the treatment of your lung nodule. Participation in this research study may last up to 18 months.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@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
Carol Sherman

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

A comparison of cell populations collected in sputum samples to cell populations in bronchoalveolar lavage samples

Date Added
October 27th, 2020
PRO Number
Pro00099320
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to analyze sputum collected from the residue remaining from bronchoalveolar lavage (BAL) procedures to compare the cellular characteristics of BAL samples to those of sputum samples collected from the acapella® airway assist device. We intend to enroll volunteers who are being evaluated by an MUSC pulmonologist as part of their standard medical care. The Control Sputum sample will be collected by volunteers at home over a three day period using an acapella® airway assist device. The cellular profiles of the BAL and sputum samples will be analyzed by flow cytometry. Active participation in this study is expected to last less than one month and will be complete once a sample is obtained from the BAL procedure.

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

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

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

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 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

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 solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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



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