A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Nonsmall Cell Lung Cancer

Date Added
March 21st, 2025
PRO Number
Pro00138993
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

The main purpose of this study is to measure overall survival (OS) and safety of ivonescimab (study drug) when combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel compared to pembrolizumab combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel. Participants will undergo screening procedures done to determine if they meet the requirements to be in this study. Screening will be completed within 28 days before receiving the study drug. Many of these screening measures are likely part of regular cancer care and may be done even if it turns out that you do not participate in the research study.

Once enrolled in the study, participants will visit the clinic every three weeks for 4 cycles of ivonescimab plus chemotherapy or pembrolizumab and chemotherapy for up to four infusions, followed by ivonescimab or pembrolizumab every three weeks for up to 24 months. If a participant's physician decides to use nab-paclitaxel chemotherapy for the first 4 cycles of treatment, the schedule of treatment is different and will require that the participant comes to the clinic for this infusion on days 1, 8, and 15 of each cycle. There will be follow-up check-up visits with the study team approximately 7 days, 30 days and 90 days after the last treatment or before the participant starts a new treatment for the cancer. Ninety (90) days after the participant stops taking the study drug, there will be a call or a visit scheduled to review how the they are feeling. This is a survival call/visit and will happen every 90 days until the end of the study. Participation in this study will last about 4 years, 2 years in active treatment and 2 years in follow up.

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

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 11th, 2025
PRO Number
Pro00146236
Researcher
Jonathan Alexander

List of Studies

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

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Protocol S2414, A Randomized Phase III Trial Incorporating Pathologic Complete Response in Participants with Early Stage Non-Small Cell Lung Cancer to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT) (NCT06498635)

Date Added
October 22nd, 2025
PRO Number
Pro00147635
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Institution
MUSC
Recruitment Contact
maggie bentley
864-725-7125
margaret.bentley@selfregional.org

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Date Added
December 18th, 2025
PRO Number
Pro00147387
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer (NSCLC). This study is testing an investigational drug called Amivantamab. "Investigational" means that is not been approved by United States Food and Drug Administration (FDA). There will be no randomization in this study. Participants will be assigned to treatment upon enrollment based on disease treatment status. The primary purpose of this study is to understand how well the study treatment works and the safety of the combination of Amivantamab and Lazertinib in participants who have NSCLC with a specific eGFR mutation. Amivantamab can be given under the skin (subcutaneous) or by infusion (IV). Participants can be in the study for up to 36 months depending on how the participants disease responds to treatment.

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

A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Date Added
December 30th, 2025
PRO Number
Pro00147394
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This is a Phase II clinical trial testing a drug called Telisotuzumab Vedotin in people who have already been treated for a specific type of lung cancer that has spread or is hard to remove with surgery. The cancer must show high levels of a protein called c-Met and have a normal version of another protein called eGFR. The main goal is to see how well the drug works and how safe it is when given in three different ways. Telisotuzumab Vedotin is a special kind of medicine that combines an antibody (which targets cancer cells) with chemotherapy. It's given through an IV (a tube in your vein), and each treatment takes about 30 minutes. Patients will get this treatment every two weeks on day one of the cycle. There will be four cycles in the study. There is also a 28 day screening window, a 30 day follow up period, post treatment follow up, and then survival follow up. The study itself will only last a few months, but the follow up will last for years. The follow up period will have limited contact compared to the main study. There will be around about 10 total study visits.

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

S2409, PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Date Added
January 16th, 2026
PRO Number
Pro00149185
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

Magnetic Cell Selection System for CD34+ Cells From HPC-Apheresis Used in Treatment of Acute Myeloid Leukemia

Date Added
January 20th, 2026
PRO Number
Pro00148616
Researcher
Alexander Coltoff

List of Studies

Keywords
Drug Studies, Men's Health, Women's Health
Summary

This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.

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

A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)

Date Added
January 21st, 2026
PRO Number
Pro00147574
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.

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



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