LUNG CANCER

22.0087: A Phase I, Open-Label, Multicenter Study of FT538 in Combination with Monoclonal Antibodies in Subjects with Advanced Solid Tumors

Principal Investigator: Jason Chesney, MD, PhD

Phase: I

Description: Primary:• To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab• To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumabSecondary:• To evaluate the anti-tumor activity of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab, using RECIST v1.1• To characterize the PK of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab (including biosimilars), cetuximab, atezolizumab, nivolumab, and pembrolizumab

More Info: https://clinicaltrials.gov/ct2/show/NCT05069935?term=NCT05069935&draw=2&rank=1


22.0189:  A Phase 1/2, open-label study of PD-1 knockout tumor-infiltrating lymphocytes (IOV-4001) in participants with unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer

Principal Investigator: Jason Chesney, MD, PhD

Description:  This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

More info:  https://clinicaltrials.gov/ct2/show/NCT05361174?term=NCT05361174&draw=2&rank=1

 

21.0839:  Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

Principal Investigator: Neal Dunlap, MD

Phase:  2/3

Description:  This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

More info:  https://clinicaltrials.gov/ct2/show/NCT04402788?term=NCT04402788&draw=2&rank=1

21.0042:  A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

Principal Investigator: Neal Dunlap, MD

Phase: III

Description: This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

More information: https://clinicaltrials.gov/ct2/show/NCT03833154?term=NCT03833154&draw=2&rank=1

08.0041:  Beta-glucan`s Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Principal Investigator: Phuong Ngo, MD

Description:  The overall goal of this study is to lay the groundwork for eventual research into the utility of oral beta-glucan in patients receiving Cetuximab. Patient participation will be separated into two groups. AIM 2 will enroll 150 patients with suspected or confirmed with NCSLC. These patients will take beta-glucan 250 mg TID for 14 days. Blood samples will be collected at baseline and after treatment. AIM 3 will enroll 150 patients who have resectable NCSLC. This group will receive beta-glucan 250 mg TID for 10 to 20 days before resection of lung tumor. Blood samples will be collected at baseline and after treatment (prior to surgery), and tissue will be collected during resection.

More info: https://clinicaltrials.gov/ct2/show/NCT00682032?term=NCT00682032&draw=2&rank=1

 

20.0986:  A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes(LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

Principal Investigator: Jason Chesney, MD, PhD

Phase:  II

Description:  This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic NSCLC.

More info:  https://clinicaltrials.gov/ct2/show/NCT04614103?term=NCT04614103&draw=2&rank=1

 

20.0535: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Principal Investigator: Neal Dunlap, MD

Phase: III

Description: This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

More info: https://clinicaltrials.gov/ct2/show/NCT04155034?term=NCT04155034&draw=2&rank=1

 

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

 

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

 

18.0336:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 

 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.II

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

 

15.0122 - CIRB - A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

Principal Investigator:  Jason Chesney, M.D., Ph.D.

Description:  This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02201992

 

15.0075 - Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).

Principal Investigator:  Jason Chesney, M.D., Ph.D.

Description:  This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02194738

 

13.0337 - The effect of pentoxifylline and Vitamin E in preventing radiation-induced toxicity in the treatment of recurrent or new primary non-small cell lung cancers using stereotactic ablative radiotherapy (SABR) in patients previously treated with thoracic radiation.

Principal Investigator: Neal Dunlap, M.D. 

Description: The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01871454?term=NCT01871454&rank=1
 

 08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1