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202 Clinical Trials near Hendersonville, TN
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerFicerafusp Alfa + Pembrolizumab for Head and Neck Cancer
Nashville, Tennessee
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Autoimmune Disease, HIV, Others
Must Not Be Taking:Anti-TGFβ, Anti-EGFR, Immunosuppressants
650 Participants Needed
177Lu-DOTA-TATE + Octreotide LAR for Neuroendocrine Tumors
Nashville, Tennessee
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 100
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Major Surgery, Others
Must Be Taking:Somatostatin Analogues
240 Participants Needed
Avexitide for Hypoglycemia
Nashville, Tennessee
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Insulinoma, Active Psychiatric Disease, Others
Must Not Be Taking:Insulin, GLP-1 Agonists, Metformin, Others
75 Participants Needed
N-803 + Tislelizumab + Docetaxel for Non-Small Cell Lung Cancer
Nashville, Tennessee
This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical region (North America vs Europe vs ASIA vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA); (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\] vs OTHER AGA vs No AGA).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis B/C, Others
Must Be Taking:Anti-retroviral Therapy
460 Participants Needed
Buntanetap for Alzheimer's Disease
Nashville, Tennessee
The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Major Depression, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
760 Participants Needed
Antimicrobial Therapy for Infections
Nashville, Tennessee
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to:
1. compare the efficacy, and
2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC).
Participants in the intervention group will receive aPDT prior to surgery on the day of surgery.
Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Surgery, Infection, Others
4514 Participants Needed
EYP-1901 vs Aflibercept for Age-Related Macular Degeneration
Nashville, Tennessee
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Subfoveal Fibrosis, Atrophy, Scarring, Others
Must Be Taking:Anti-VEGF Injections
400 Participants Needed
Baricitinib for Post-COVID Syndrome
Nashville, Tennessee
The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Suicidality, Cardiovascular Event, Others
Must Not Be Taking:Baricitinib, DMARDs, Probenecid
550 Participants Needed
EYE103 for Diabetic Macular Edema
Nashville, Tennessee
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cataract Surgery, Others
Must Not Be Taking:Retinal Toxicity Drugs
984 Participants Needed
Elritercept for Myelodysplastic Syndrome
Nashville, Tennessee
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Stroke, HIV, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Others
225 Participants Needed
Axitinib Implant for Age-Related Macular Degeneration
Nashville, Tennessee
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Monocular, Scar, Fibrosis, Atrophy, Others
Must Be Taking:Aflibercept
825 Participants Needed
Paclitaxel-Coated Balloon Catheter for Stent Restenosis
Nashville, Tennessee
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Heart Failure, Substance Abuse, Others
Must Not Be Taking:Antiplatelets, Anticoagulants
20 Participants Needed
BHV-7000 for Epilepsy
Nashville, Tennessee
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Repetitive Seizures, Others
Must Be Taking:Antiseizure Medications
242 Participants Needed
Gene Therapy for Retinitis Pigmentosa
Nashville, Tennessee
This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.
This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5+
Key Eligibility Criteria
Disqualifiers:Glaucoma, Retinal Detachment, Others
150 Participants Needed
Dichoptic Treatment for Lazy Eye
Nashville, Tennessee
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:4 - 7
Key Eligibility Criteria
Disqualifiers:Heterotropia, Prism Lenses, Myopia, Others
Must Not Be Taking:Cycloplegic Eyedrops
238 Participants Needed
UGN-103 for Bladder Cancer
Nashville, Tennessee
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HG Bladder Cancer, Neurogenic Bladder, Others
Must Not Be Taking:BCG Treatment
92 Participants Needed
BI 1015550 for Pulmonary Fibrosis
Nashville, Tennessee
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Suicidality, Severe Depression, Malignant Neoplasm, Others
Must Be Taking:Nerandomilast
1700 Participants Needed
VE303 for C. Difficile Infection
Nashville, Tennessee
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Chronic Diarrhea, Celiac, Others
Must Be Taking:Standard Antibiotics
852 Participants Needed
Axitinib Implant for Age-Related Macular Degeneration
Nashville, Tennessee
This trial is testing a small device placed in the eye that releases medication for patients with a severe form of AMD. The medication helps stop abnormal blood vessel growth in the eye, potentially preventing further vision loss. This approach has significantly improved treatment for this condition in recent years.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Monocular, Scar, Fibrosis, Atrophy, Others
344 Participants Needed
Zongertinib for Lung Cancer
Nashville, Tennessee
This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy.
Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein.
Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Malignancies, Severe Illness, Cardiovascular, Others
Must Not Be Taking:Restricted Medications
416 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
Vagus Nerve Stimulation for PWS
Nashville, Tennessee
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 40
Key Eligibility Criteria
Disqualifiers:Pregnancy, Serious Mental Illness, Cardiac Disease, Epilepsy, Others
102 Participants Needed
Belumosudil + Corticosteroids for Chronic Graft Versus Host Disease
Nashville, Tennessee
This trial is testing a new treatment for people with moderate or severe chronic GVHD. It targets newly diagnosed patients who may not respond well to existing treatments. The goal is to manage or reduce the symptoms of chronic GVHD.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Pregnancy, HIV, Hepatitis B, Others
Must Be Taking:Corticosteroids
260 Participants Needed
BHV-7000 for Epilepsy
Nashville, Tennessee
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
Ivosidenib for Chondrosarcoma
Nashville, Tennessee
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.
Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Brain Metastases, Cardiac Disease, Others
Must Not Be Taking:IDH1 Inhibitors, Steroids
136 Participants Needed
AMX0035 for Progressive Supranuclear Palsy
Nashville, Tennessee
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Schizophrenia, Bipolar, Depression, Others
110 Participants Needed
Fat Cell Injections for Knee Osteoarthritis
Nashville, Tennessee
This trial is testing an injection of a patient's own processed fat tissue to treat knee pain and improve function in people with moderate knee osteoarthritis. The fat tissue is thought to help by cushioning the joint and possibly aiding in healing. This treatment has been studied for its potential to improve pain and function in patients with knee osteoarthritis.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Rheumatoid Arthritis, Infection, Obesity, Others
Must Not Be Taking:Corticosteroids, Anti-coagulants
173 Participants Needed
Bronchoscopy + Cryobiopsy for Lung Cancer
Nashville, Tennessee
This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Under 18, Pregnant, Prisoner, Others
250 Participants Needed
Tele-Collaborative Care for Chronic Pain
Nashville, Tennessee
This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Terminal Illness, Others
608 Participants Needed
MK-2870 for Non-Small Cell Lung Cancer
Nashville, Tennessee
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Squamous NSCLC, Cardiovascular Disease, Pneumonitis, Others
Must Be Taking:EGFR TKIs
556 Participants Needed
Ecopipam for Tourette Syndrome
Nashville, Tennessee
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to \[\>=\] 6 and less than \[\<\] 12 years of age), adolescents (\>=12 and \<18 years of age), and adults (\>=18 years of age) with Tourette's Syndrome (TS).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6+
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Mood Disorders, Others
Must Be Taking:Ecopipam
150 Participants Needed
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