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218 Clinical Trials near Acworth, GA
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 PowerUpadacitinib vs Adalimumab for Rheumatoid Arthritis
Marietta, Georgia
This trial is testing two medications, upadacitinib (a daily pill) and adalimumab (an injection), for adults with rheumatoid arthritis who haven't responded to other treatments. The study aims to see which drug is safer and more effective. Both medications work by reducing inflammation through different mechanisms in the immune system. Adalimumab, an injection, has been extensively studied and used for treating rheumatoid arthritis, showing significant improvements in patients who have not responded to other treatments.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Juvenile Arthritis, Non-RA Inflammatory Joint, Others
Must Be Taking:Methotrexate
487 Participants Needed
Orforglipron for Type 2 Diabetes and Obesity
Woodstock, Georgia
This trial is testing a new diabetes medication called orforglipron to see if it is safer and more effective than insulin in people with type 2 diabetes who are overweight or obese and at higher risk for heart problems. The study will last several years and involve multiple visits.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pancreatitis, Others
Must Be Taking:Oral Antihyperglycemics
2749 Participants Needed
This trial tests whether adding a precise form of radiation therapy to the usual treatment improves outcomes for patients with advanced lung cancer that can't be operated on. The goal is to see if this combination helps patients live longer and prevents cancer from worsening. This form of radiation therapy has shown promise in improving survival rates in patients with various stages of lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Radiotherapy, Pregnancy, Others
474 Participants Needed
Deucravacitinib for Lupus
Marietta, Georgia
This trial is testing a new medication called deucravacitinib to see if it is safe and effective for people with moderate to severe lupus, a disease where the immune system attacks the body. The medication aims to reduce inflammation by targeting specific enzymes in the immune system.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Drug-induced SLE, Other Autoimmune Diseases, Active Lupus Nephritis, Others
Must Be Taking:Immunosuppressant, Antimalarial
513 Participants Needed
This trial compares pembrolizumab alone and in combination with sacituzumab govitecan in adults with advanced lung cancer who have high levels of a certain protein. Pembrolizumab boosts the immune system to fight cancer, while sacituzumab govitecan targets and kills cancer cells. Pembrolizumab has been used as a standard treatment for a type of lung cancer, showing improved survival rates compared to other treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Second Malignancy, Cardiac Disease, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors, Trop-2 Therapy
614 Participants Needed
BLI5100 for Erosive Esophagitis
Marietta, Georgia
This trial tests BLI5100, an oral medication, in patients with Erosive Esophagitis (EE). It aims to see if BLI5100 can heal the esophagus and maintain its healing.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Esophageal Stricture, Barrett's Esophagus, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Anxiolytics, Others
1250 Participants Needed
Tirzepatide for Obesity
Woodstock, Georgia
This trial is testing tirzepatide, a medication that helps control blood sugar and reduce appetite, to see if it can lower health problems and death rates in adults who are very overweight. Tirzepatide was developed by Eli Lilly to improve blood sugar control in adults with type 2 diabetes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Diabetes, Recent MI, Pancreatitis, Others
15374 Participants Needed
Remternetug for Alzheimer's Disease
Woodstock, Georgia
This trial tests remternetug, a drug given by injection or IV, in people with early Alzheimer's disease. It aims to find out if the drug is safe and can help improve symptoms or slow down the disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85
Key Eligibility Criteria
Disqualifiers:Unstable Illnesses, Cancer, Psychiatric Diagnosis, Others
Must Not Be Taking:Anti-amyloid Immunotherapy
1667 Participants Needed
RGX-314 Gene Therapy for Age-Related Macular Degeneration
Marietta, Georgia
This trial is testing a new one-time gene therapy called RGX-314 for patients with wet AMD. The goal is to reduce the need for regular treatments by helping the eye produce its own protective proteins. This could make treatment easier and more effective for patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 89
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Advanced Glaucoma, Others
Must Be Taking:Anti-VEGF
660 Participants Needed
Sacituzumab Govitecan for Triple-Negative Breast Cancer
Cartersville, Georgia
This trial is testing a drug called sacituzumab govitecan-hziy, which targets and kills cancer cells. It focuses on patients with advanced triple-negative breast cancer who have limited treatment options. The drug works by attaching to cancer cells and releasing a substance that kills them. Sacituzumab govitecan-hziy is an FDA-approved treatment for metastatic triple-negative breast cancer, especially for patients who have already tried other treatments.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Active Infection, Second Malignancy, Others
Must Not Be Taking:Topoisomerase Inhibitors
623 Participants Needed
RTX-GRT7039 Injections for Knee Osteoarthritis
Woodstock, Georgia
This trial uses knee injections called RTX-GRT7039 for patients with knee osteoarthritis who still have pain despite usual treatments. The injections aim to reduce knee pain, possibly by affecting pain pathways or inflammation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Joint Replacement, Significant Trauma, Hip Osteoarthritis, Others
930 Participants Needed
mRNA-1345 Vaccine for Respiratory Syncytial Virus
Marietta, Georgia
This trial is testing a new vaccine called mRNA-1345 to see if it can prevent lung infections caused by the RSV virus. The vaccine works by teaching the body to recognize and fight the virus. The study will include people who are at risk of these infections and will compare the effects of the vaccine to a non-treatment group.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Guillain-Barré, Other Vaccines, Others
36814 Participants Needed
Donanemab for Alzheimer's Disease
Woodstock, Georgia
This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:65 - 80
Key Eligibility Criteria
Disqualifiers:Mild Cognitive Impairment, Dementia, Cancer, Others
Must Not Be Taking:Cognitive Enhancers
2996 Participants Needed
Pembrolizumab + Chemotherapy for Breast Cancer
Marietta, Georgia
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Active Infection, CNS Metastases, Others
Must Be Taking:CDK4/6 Inhibitors
340 Participants Needed
Semaglutide for Non-alcoholic Steatohepatitis
Marietta, Georgia
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.
Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.
Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.
The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.
Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Alcohol Use, Others
Must Not Be Taking:Vitamin E, Pioglitazone, GLP-1 RAs, Others
1205 Participants Needed
Talazoparib + Enzalutamide for Metastatic Prostate Cancer
Cartersville, Georgia
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Seizure History, Brain Metastasis, Cardiovascular Disease, Others
Must Be Taking:GnRH Agonists/antagonists
599 Participants Needed
Pegcetacoplan for Age-Related Macular Degeneration
Marietta, Georgia
This trial is testing a medication called pegcetacoplan to see if it is safe and effective for people with a severe eye condition called geographic atrophy, which is related to age-related macular degeneration. The medication aims to protect the eye by blocking harmful immune responses. Pegcetacoplan has shown an acceptable safety profile in previous studies for geographic atrophy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Eye Diseases, Eye Inflammation, Allergies, Pregnancy, Others
1200 Participants Needed
Itepekimab for COPD
Woodstock, Georgia
Primary Objective:
Primary population (former smokers cohort):
* Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
Primary population (former smokers cohort):
* Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
* Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Secondary population (current smokers cohort)
* Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
* Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
* Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
* Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
* Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40 - 85
Key Eligibility Criteria
Disqualifiers:Asthma, Pulmonary Disease, Hypertension, Others
Must Be Taking:Inhaled Corticosteroids, Long-acting Beta-agonists
1239 Participants Needed
RGX-314 Gene Therapy for Wet Age-Related Macular Degeneration
Marietta, Georgia
This trial is testing a new one-time gene therapy called RGX-314 for patients with wet AMD. It aims to help the eye make its own medicine to stop harmful blood vessels from causing vision loss. This could reduce the need for regular injections. RGX-314 modifies the retina's cells to create a treatment that may only be needed once.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:50 - 89
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Advanced Glaucoma, Others
Must Be Taking:Anti-VEGF
630 Participants Needed
Adagrasib vs Docetaxel for Non-Small Cell Lung Cancer
Cartersville, Georgia
This trial is testing a new drug called adagrasib against an existing chemotherapy drug, docetaxel. It focuses on patients with advanced lung cancer who have a specific genetic mutation (KRAS G12C) and have already had treatment. The new drug aims to block this mutation in cancer cells to stop their growth.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Brain Metastases, Others
Must Not Be Taking:KRAS G12C Inhibitors
453 Participants Needed
Why Other Patients Applied
"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
"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 was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"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
This trial is testing if adding two drugs, tafasitamab and lenalidomide, to an existing treatment (rituximab) is more effective than just adding one drug (lenalidomide) for patients with certain types of lymphoma that have returned or not responded to treatment. The drugs aim to better target and destroy cancer cells while boosting the body's immune response against the cancer. Lenalidomide has shown activity in various lymphoma subtypes, including diffuse large B-cell lymphoma, and is often combined with rituximab for enhanced efficacy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Non-hematologic Malignancy, Others
Must Be Taking:Rituximab
654 Participants Needed
LOXO-305 for Chronic Lymphocytic Leukemia
Marietta, Georgia
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Richter's Transformation, CNS Involvement, Others
Must Be Taking:BTK Inhibitors
238 Participants Needed
Adagrasib + Pembrolizumab for Lung Cancer
Marietta, Georgia
This trial tests two drugs, MRTX849 and pembrolizumab, in patients with advanced lung cancer who have a specific genetic mutation. MRTX849 targets the mutation to stop cancer growth, while pembrolizumab boosts the immune system to fight the cancer. The study aims to see how well these treatments work alone and together.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Active Brain Metastases, Seizures, Others
Must Not Be Taking:Chemotherapy, Immune Checkpoint Inhibitors
806 Participants Needed
Atezolizumab + Tiragolumab for Lung Cancer
Marietta, Georgia
The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV NSCLC, Autoimmune Disease, EGFR Mutation, ALK Fusion, Others
Must Not Be Taking:Immunosuppressants
829 Participants Needed
Atezolizumab + Chemotherapy for Small Cell Lung Cancer
Marietta, Georgia
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:
* Arm A: Tiragolumab plus atezolizumab plus CE
* Arm B: Placebo plus atezolizumab plus CE
Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Autoimmune Disease, HIV, Others
Must Not Be Taking:Immunostimulatory Agents
490 Participants Needed
Mirikizumab for Crohn's Disease
Marietta, Georgia
This trial is testing mirikizumab to see if it can help people with Crohn's disease feel better over a long time and ensure it is safe. The drug works by reducing gut inflammation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Important Infections, Hypersensitivity, Others
996 Participants Needed
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, CNS Metastases, Others
Must Not Be Taking:MMAE-based ADCs, PD-(L)-1 Inhibitors
886 Participants Needed
This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W).
The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Stroke, Atrial Fibrillation, Others
Must Not Be Taking:Antimitotics, Antimetabolites
634 Participants Needed
Deucravacitinib for Psoriasis
Marietta, Georgia
The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Tuberculosis, Others
1466 Participants Needed
Tucatinib + T-DM1 for Breast Cancer
Marietta, Georgia
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.
Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Untreated Brain Lesions, Leptomeningeal Disease, Others
Must Be Taking:T-DM1
466 Participants Needed
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