The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.
Our objective is to assess whether the use of high flow nasal cannula (Vapotherm, Exeter, NH) with monitored anesthesia care (MAC) during an endobronchial ultrasound (EBUS) bronchoscopy procedure will lead to less procedure interruptions, less hypoxic episodes, shorter duration of hypoxic episodes and shorter procedural durations when compared to regular MAC using a regular nasal canula.
Lung Cancer· The Cooper Health System· Camden, New Jersey
The study is a single-arm phase I trial to evaluate the safety, feasibility, and preliminary efficacy of the addition of pembrolizumab and image-guided resection to surgical therapy and chemotherapy for malignant pleural mesothelioma (MPM).
Mesotheliomas Pleural· Abramson Cancer Center at Penn Medicine· Philadelphia, Pennsylvania
This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Advanced Lung Non-Small Cell Carcinoma· National Cancer Institute (NCI)· Fairbanks, Alaska · Fort Smith, Arkansas +3 more
The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.
Adenocarcinoma of Lung· Lantern Pharma Inc.· Beverly Hills, California · Fountain Valley, California +3 more
This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Cholangiocarcinoma· University of Pennsylvania· Philadelphia, Pennsylvania
This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Advanced Lung Neuroendocrine Tumor· National Cancer Institute (NCI)· Beverly Hills, California · Los Angeles, California +3 more
The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors.
The main questions it aims to answer are:
* To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A)
* To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B)
* To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK)
* To evaluate if antibodies to the study drug develop (immunogenicity)
* To evaluate preliminary efficacy to the drug
* To correlate preliminary efficacy with mutations in a biomarker called EGFR
Participants will:
* Provide written informed consent
* Undergo screening tests to ensure they are eligible for study treatment
* Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
* Be followed for progression every 3 months for up to 2 years
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. 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. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.
Lung Non-Small Cell Carcinoma· National Cancer Institute (NCI)· Beverly Hills, California · Los Angeles, California +3 more
This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer
Metastatic Non Small Cell Lung Cancer· Iovance Biotherapeutics, Inc.· Chicago, Illinois· Ages 18–70
Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.
Background:
Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD. Researchers want to learn if using a lower dose of cyclophosphamide may reduce the drug's side effects while maintaining its effectiveness. Such an approach is being used in an ongoing clinical study at the NIH with promising results, but this approach has not been tested for transplants using lower doses of chemotherapy/radiation prior to the transplant.
Objective:
To learn if using a lower dose of cyclophosphamide will help people have a successful transplant and have fewer problems and side effects.
Eligibility:
Adults ages 18-85 who have a blood cancer that did not respond well to standard treatments or is at high risk for relapse without transplant, and their donors.
Design:
Participants may be screened with the following:
Medical history
Physical exam
Blood and urine tests
Heart and lung tests
Body imaging scans (they may get a contrast agent)
Spinal tap
Bone marrow biopsy
Participants will be hospitalized for 4-6 weeks. They will have a central venous catheter placed in a chest or neck vein. It will be used to give medicines, transfusions, and the donor cells, and to take blood. In the week before transplant, they will get 2 chemotherapy drugs and radiation. After the transplant, they will get the study drug for 2 days. They will take other drugs for up to 2 months.
Participants must stay near NIH for 3 months after discharge for weekly study visits. Then they will have visits every 3-12 months until 5 years after transplant.
Participants and donors will give blood, bone marrow, saliva, cheek swab, urine, and stool samples for research.
Hematologic Neoplasms· National Cancer Institute (NCI)· Bethesda, Maryland · Philadelphia, Pennsylvania· Ages 12–85
This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.
This is a Phase 1/2, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic mesothelioma or other Advanced solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection expansion part (Part 2).
Malignant Mesothelioma· InSilico Medicine Hong Kong Limited· Chicago, Illinois
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:
1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
2. Is the effectiveness of these telehealth strategies similar by race and sex?
The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.
Early Detection of Cancer· Abramson Cancer Center at Penn Medicine· Philadelphia, Pennsylvania· Ages 50–80
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.
Recurrent Lung Non-Small Cell Carcinoma· SWOG Cancer Research Network· Daphne, Alabama · Fairhope, Alabama +3 more
This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.
Recurrent Lung Non-Small Cell Carcinoma· SWOG Cancer Research Network· Daphne, Alabama · Fairhope, Alabama +3 more
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[212Pb\]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3 positive tumors.
Large Cell Neuroendocrine Carcinoma· Molecular Partners AG· Atlanta, Georgia · Glen Burnie, Maryland +3 more