24.0560:  A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable older adult with Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study 

Principal Investigator: Jason Chesney, MD, PhD 

Phase:  III 

Description:  This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06096844?term=NCT06096844&rank=1

24.0420:  S2302, PRAGMATICA - LUNG - A PROSPECTIVE RANDOMIZED STUDY OF RAMUCIRUMAB (LY3009806; NSC 749128) PLUS PEMBROLIZUMAB (MK-3475; NSC 776864) VERSUS STANDARD OF CARE FOR PARTICIPANTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER 

Principal Investigator: Goetz Kloecker MD, MBA, MSPH 

Phase:  III 

Description:  This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05633602?term=NCT05633602&rank=1

24.0297:  A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

Principal Investigator: Goetz Kloecker MD, MBA, MSPH

Phase:  II

Description:  The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT04613596?term=NCT04613596&rank=1

23.0867:  A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50% 

Principal Investigator: Goetz Kloecker MD, MBA, MSPH 

Phase:  III 

Description:  The primary objective of the study is to compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of MK-2870 and pembrolizumab is superior to pembrolizumab alone with respect to OS.All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment. 

More Info:  https://clinicaltrials.gov/study/NCT06170788?term=NCT06170788&rank=1

23.0751:  A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer 

Principal Investigator: Goetz Kloecker MD, MBA, MSPH 

Phase:  III 

Description:  The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

More Info:  https://clinicaltrials.gov/study/NCT06077760?term=NCT06077760&rank=1

23.0731:  A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors 

Principal Investigator: Rohit Kumar, MD 

Phase:  II 

Description:  This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). The dose of FF-10832 may be reduced to 30 mg/m2 and tested in 10 patients after review of safety data by a safety review committee (SRC). Lower or intermediate doses of FF-10832 may be explored if necessary After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC.The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab. 

More Info:  https://clinicaltrials.gov/study/NCT05318573?term=NCT05318573&rank=1

23.0042:  A Phase 1/2, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a monotherapy and in combination with nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications 

Principal Investigator: Rebecca Redman, MD 

Phase:  I/II

Description:  DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors.

More info:  https://clinicaltrials.gov/study/NCT05597839?term=NCT05597839&rank=1

22.0602: A Global Study to Assess the Effects of Durvalumab + Domvanalimab FollowingConcurrent Chemoradiation in Participants with Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8)

Principal Investigator: Phuong Ngo, MD

Phase:  III

Description:  This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

More info:  https://clinicaltrials.gov/ct2/show/NCT05211895?term=NCT05211895&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

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

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 

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.