Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
RecruitingThis study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 65 more
SponsorGenmab
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
RecruitingNon-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 60 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
NCT05498428 · Carcinoma, Non-small-Cell Lung
RecruitingThe purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
PhasePhase 2
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 109 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
NCT06244771 · Advanced Solid Tumors With KRAS G12C Mutations, Solid Tumor, Adult, Unresectable Solid Tumor
RecruitingThe goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 25 more
SponsorFrontier Medicines Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT06667076 · Carcinoma, Non-Small-Cell Lung
RecruitingThe primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
PhasePhase 2
TypeInterventional
Age18 Years
WhereDaphne, Alabama, United States + 202 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pan-tumor MRD Study
NCT06605404 · Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
RecruitingThe purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back. Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.
Phase—
TypeObservational
Age18 Years
WhereSan Diego, California, United States + 1 more
SponsorParadigm Health
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 14 more
SponsorNuvectis Pharma, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Registry for People With Lung Cancer
RecruitingParticipants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
Phase—
TypeObservational
Age18 Years
WhereTucson, Arizona, United States + 17 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
NCT06500481 ·
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Non-Small Cell Carcinoma
RecruitingThis phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 57 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
NCT07144280 · Non-small Cell Carcinoma,
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Carcinoma
RecruitingThe purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAlabaster, Alabama, United States + 430 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
NCT06400472 · Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
RecruitingThe purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 23 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
RecruitingNon-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereSpringdale, Arkansas, United States + 115 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
RecruitingThis Phase 2 study will be conducted in different countries around the world with up to about 240 participants. The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo. The treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
PhasePhase 2
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States + 73 more
SponsorGenmab
▾Tap for detailsClick for full details — eligibility, all locations, contacts Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer
NCT06577883 ·
Lung Cancer RecruitingThe goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are: * What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule? * Can artificial intelligence help us detect lung cancer on chest tomosynthesis images? Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer. Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.
Phase—
TypeObservational
Age30 Years – 85 Years
WhereSan Diego, California, United States
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
NCT06465069 · Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor
RecruitingThe purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 38 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
NCT06031688 · Recurrent Lung Non-Small Cell Carcinoma,
Stage IV Lung Cancer AJCC v8 RecruitingThis 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.
PhasePhase 2
TypeInterventional
Age18 Minutes
WhereDaphne, Alabama, United States + 265 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
RecruitingResearchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 278 more
SponsorBayer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
NCT06116682 · Lung Non-Small Cell Carcinoma
RecruitingThis phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.
PhasePhase 2
TypeInterventional
Age18 Years
WhereJonesboro, Arkansas, United States + 247 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts Retifanlimab and Ruxolitinib In Solid Malignancies
NCT07219576 · Non Small Cell Lung Carcinoma, Renal Cell Carcinoma
RecruitingThe goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma. The main question it aims to answer is: What is the maximum dose of ruxolitinib that can be used safely in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma, and will it work? Participants will: Take drug ruxolitinib twice a day and keep a diary of when they take ruxolitinib at home; visit the clinic for infusions of retifanlimab every 4 weeks; visit the clinic for checkups and tests.
PhasePhase 1 / Phase 2
TypeInterventional
AgeAny
WhereLa Jolla, California, United States
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RecruitingThis clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma. The study will start with monotherapy dose escalation followed by combination cohorts.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 2 more
SponsorBioEclipse Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts