DECEMBER 2023 CLINICAL CORNER

Robotic Technology Streamlines Lung Cancer Diagnosis

Lung cancer is the deadliest cancer, claiming a disproportionate number of lives compared with the next leading cancers combined: breast, prostate and colon. The absence of symptoms at onset and the ability for the disease to spread quickly and silently can lead to an advanced diagnosis.

“There is a substantial benefit of lung cancer screening,” said Hiren Mehta, MD, a professor of medicine in the University of Florida Division of Pulmonary Medicine. “The way lung cancer screening improves survival is by catching cancer at a much earlier stage, way before it starts spreading.”

Typically, when a patient is diagnosed with a suspicious nodule or mass in their lung, they are referred to a pulmonologist, who performs one or more lung biopsies, to confirm if it’s cancerous. This process can take some time, causing anxiety for the patient.

Now with robotic tools, physicians can quickly and safely access and biopsy difficult-to-reach nodules in the peripheral lung — where more than 70% of cancer lung nodules are located — streamlining diagnosis and treatment.


New Clinical Trials Open for Enrollment

Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (EXPAND)

This is a Phase 2 randomized trial assessing the safety and efficacy of ALLO-647 combined with Flu/Cy compared to Flu/Cy alone as a lymphodepletion regimen prior to ALLO-501A CAR T therapy for patients with relapsed/refractory large B-cell lymphoma. ALLO-647 is a novel human IgG1 monoclonal antibody that recognizes the human CD52 antigen. ALLO-501A is a pre-manufactured, TCRαβ depleted T cell suspension designed to become active, proliferate, secrete cytokines and kill CD19+ B cells following administration to lymphodepleted subjects with relapsed/refractory LBCL. The goal of this lymphodepletion strategy is to deplete endogenous lymphocytes to allow an improved clinical response of allogeneic CAR T cells. 

Principal Investigator: Erin Dean, M.D.

NP-G2-044 in Combination with anti-PD-1 Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies

This is a Phase 2 trial of a novel fascin inhibitor (NP-G2-044) given in combination with standard of care anti-PD1 treatment, in solid tumor subjects with prior progression on anti-PD1 treatment. Subjects will received oral NP-G2-044, once daily on days 1-28 of a 28-day cycle, in addition to anti-PD1 therapy in accordance with the package insert.  Primary study objective is to assess preliminary anti-tumor efficacy of NP-G2-044 when administered in combination with anti-PD1 therapy. 

Principal Investigator: Thomas George, M.D., FACP 

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy for Limited mCRC (ERASur)

This phase III trial compares total ablative therapy (TAT) and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The ablative local therapy will consist of stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for Limited mCRC. This study is based on current common practice, and will pragmatically evaluate the safety, benefits versus risks, and survival impact of the integration of these treatments for Limited mCRC. 

PI: Kathryn Hitchcock, M.D.

A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev)(NUC-3373 Q1 week versus Q2 weeks on a 28-day cycle) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.  The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

Principal Investigator: Thomas George, M.D.