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 AZD9291 (Osimertinib) and Bevacizumab Versus AZD9291 (Osimertinib) 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 Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

Date Added
November 17th, 2020
PRO Number
Pro00105404
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This study is for patients that have been diagnosed with extensive stage small cell lung cancer. The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The study drug involved is atezolizumab. Participants can expect to be on this study for up to 5 years or until disease progression.

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

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 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

Early Immune Biomarker Detection of Lung Cancer

Date Added
August 18th, 2020
PRO Number
Pro00097432
Researcher
Carsten Krieg

List of Studies


Keywords
Cancer/Lung
Summary

The purpose of this study is to look at the changes in blood and tissue samples over time of patients with suspicion for lung cancer, pre-cancerous lung nodules, and newly diagnosed lung cancer.

Institution
MUSC
Recruitment Contact
HCC CTO
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



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