The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.
This study is recruiting patients who have advanced non-small cell lung cancer (NSCLC) with a KRAS mutation whose cancer has not responded to standard of care treatment. (All human cells have a gene called KRAS. If cells have a KRAS mutation, the cells may multiply out of control which can cause cancer.) This study has two parts. The first part of the study is being done to find the safety, tolerability and safe dose of a study drug called BBP-398 when it is used in combination with another drug that has already been approved for use by the Food and Drug Administration, called Nivolumab. The second part of the study is being done to further understand the how tumors are affected by the study drug, BBP-398, and Nivolumab. About 26 patients in the United States will participate in this study. You may be eligible if you have NSCLC with a KRAS mutation that has not responded to standard treatment. Patients who enroll in this study will be required to come to MUSC for study treatments and follow-up visits. The participation in the study can last up to 2 years with a follow up period of 3 years.
This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.
There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.
During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.
This is a 2 Part, Phase 3, open-label, randomized study to sequentially demonstrate the pharmacokinetic noninferiority of amivantamab SC-CF administered via manual injection compared with amivantamab IV (Part 1) and the bioequivalence of amivantamab SC-CF administered via a manual injection versus amivantamab subcutaneous, co-formulated with recombinant human hyaluronidase, and delivered with an on-body delivery system (SC-CF OBDS; Part 2). The combination product of the device (on-body delivery system; OBDS) plus the study drug amivantamab SC-CF (hereafter referred to as amivantamab SC-CF OBDS) is provided as a completely assembled, ready to use, single-use product. It is preloaded with a prefilled liquid drug product vial, thereby eliminating the need for drug preparation by a pharmacist. The formulation of amivantamab SC-CF used in amivantamab SC-CF OBDS is identical to the manual injection formulation of amivantamab SC-CF (but differs from the IV formulation).
Lazertinib (JNJ-73841937) is an oral, highly potent, third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) with no demonstrated pharmacokinetic (PK) interaction with amivantamab. It selectively inhibits both activating EGFR mutations (Exon 19del, L858R) and the EGFR T790M resistance mutation
while showing mutant-selective activity for EGFR.
The primary objectives are to assess the pharmacokinetic noninferiority of amivantamab SC-CF via manual injection versus amivantamab IV (Part 1) and to assess the bioequivalence of amivantamab SC-CF via manual injection and amivantamab SC-CF OBDS (Part 2). Key secondary objectives are to assess efficacy (objective response rate [ORR] and progression-free survival [PFS]) and safety of the different administrations.
This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.
This study is for patients who have been diagnosed with small cell lung cancer (SCLC). The investigational drug in the study is AMG 757. Both drugs are immunotherapy treatments, medicines that work with your immune system to help fight cancer. AMG 757 will be given in a liquid form directly into participants' veins (intravenously). This study is being done to find out about the safety and efficacy (effects good or bad) of AMG 757 for the treatment of SCLC. Participants can expect to receive treatment for about 24 months.
The duration of AMG 757 treatment will depend on how the disease responds to the investigational drugs and how the body tolerates AMG 757. So, participation may be longer or shorter than this window. The study period includes screening period lasting up to 21 days, a treatment period, a first safety follow-up visit, and a second safety follow-up visit. This will be followed by long-term follow-up visits up to 1 year from the first dose of AMG 757 for a total of about 3 years in the study.
This study is for patients who have been diagnosed with advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.
This study is for patients who have been diagnosed with metastatic Non-Small Cell Lung Cancer (NSCLC). The investigational drug in this study is Mecbotamab Vedotin (BA3011). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Mecbotamab Vedotin by intravenous (IV) infusion. The purpose of this study is to understand how Mecbotamab Vedotin works with and without nivolumab in fighting cancer cells; to see what side effects Mecbotamab Vedotin has when given alone and in combination with nivolumab; to understand how the body absorbs and processes Mecbotamab Vedotin; and to understand whether Mecbotamab Vedotin, alone or in combination with nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body). Participants can expect to be in this study for about 2 and a half years.
This study is for patients who have been diagnosed with non-small cell lung cancer. The investigational drug in this study is Ozuriftamab Vedotin (BA3021). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Ozuriftamab Vedotin by intravenous (IV) infusion. The purpose of this study is to see how Ozuriftamab Vedotin alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe Ozuriftamab Vedotin is alone and in combination with nivolumab; to understand how the body absorbs and processes Ozuriftamab Vedotin; to understand whether Ozuriftamab Vedotin, alone or in combination with Nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase your risk of side effects. Participants can expect up to 75 clinic visits over a period of about 3 years.
This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.