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190 Clinical Trials near Edison, NJ
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 PowerLazertinib + Amivantamab for Non-Small Cell Lung Cancer
New Brunswick, New Jersey
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Leptomeningeal Disease, ILD, Others
Must Be Taking:EGFR Inhibitors
418 Participants Needed
Sacituzumab Govitecan + Pembrolizumab for Triple-Negative Breast Cancer
New Brunswick, New Jersey
This trial compares the effectiveness of a combination of two drugs, SG and pembrolizumab, in patients with advanced triple-negative breast cancer. SG targets and kills cancer cells with chemotherapy, while pembrolizumab helps the immune system attack the cancer. Pembrolizumab has been shown to improve survival in various cancers, including triple-negative breast cancer, when used alone or in combination with 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, Autoimmune, Others
Must Not Be Taking:Topoisomerase Inhibitors
443 Participants Needed
Inclisiran + Statins for Coronary Artery Disease
Somerset, New Jersey
This trial is testing inclisiran, an injectable medication, to see if it can reduce plaque in heart arteries of patients with non-obstructive coronary artery disease who have not had previous heart events. Inclisiran works by lowering 'bad' cholesterol levels in the blood.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Events, Cerebrovascular Events, PAD, Others
Must Be Taking:Statins
610 Participants Needed
Early Radiation Therapy for Cancer
New Brunswick, New Jersey
To determine if the experimental approach of early radiation oncology involvement alongside standard oncologic care will result in higher HRQL at 6 months compared to the control arm receiving standard oncologic care alone, based on the global subscale score of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Castrate-sensitive Prostate, Breast, Endometrial, Others
156 Participants Needed
Abatacept for Myocarditis
New Brunswick, New Jersey
This Trial tests if abatacept can reduce serious heart problems in patients with heart inflammation caused by cancer treatments. Abatacept calms the immune system by preventing certain immune cells from becoming fully active, reducing inflammation and damage. Abatacept has been approved by the US Food and Drug Administration for the treatment of rheumatoid arthritis, with or without methotrexate.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infections, Pregnancy, Recent Cardiac Events, Others
Must Be Taking:Solumedrol
390 Participants Needed
Nivolumab-relatlimab Combo for Colorectal Cancer
East Brunswick, New Jersey
This trial is testing a combination of two drugs, relatlimab and nivolumab, for patients with a certain type of colorectal cancer who haven't responded to other treatments. The drugs help the immune system attack the cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Untreated CNS Metastases, Refractory Hypertension, Others
Must Not Be Taking:Immunotherapy, Regorafenib, TAS-102
700 Participants Needed
Chemotherapy for Rhabdomyosarcoma
New Brunswick, New Jersey
This trial uses chemotherapy drugs to treat patients with very low-risk and low-risk rhabdomyosarcoma. The goal is to maintain good outcomes while reducing treatment intensity. The study also examines if patients with specific DNA mutations benefit from more intensive therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 21
Key Eligibility Criteria
Disqualifiers:Prior Chemotherapy, Radiation, Uncontrolled Infection, Others
Must Not Be Taking:CYP3A4 Inhibitors, Inducers
205 Participants Needed
Pembrolizumab/Vibostolimab + Chemoradiotherapy for Non-Small Cell Lung Cancer
New Brunswick, New Jersey
This trial tests a combination of two drugs, pembrolizumab and vibostolimab, along with standard chemotherapy and radiation in patients with advanced lung cancer that cannot be surgically removed. The goal is to see if this combination can better control the disease and improve survival compared to another drug, durvalumab. These drugs help the immune system attack cancer cells more effectively.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:SCLC, Immunodeficiency, Autoimmune, Others
Must Not Be Taking:Steroids, Immunosuppressants, NSAIDs, Others
611 Participants Needed
Itolizumab + Corticosteroids for Acute Graft-Versus-Host Disease
New Brunswick, New Jersey
This trial is testing itolizumab, an IV medication, in patients with severe aGVHD. It aims to see if itolizumab can better control the immune system and reduce inflammation. Itolizumab has been used in various conditions including psoriasis, rheumatoid arthritis, and COVID-19.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Relapsed Malignancy, CGVHD, Others
Must Be Taking:Corticosteroids
200 Participants Needed
Savolitinib + Osimertinib for Non-Small Cell Lung Cancer
New Brunswick, New Jersey
This trial is testing a new drug combination for lung cancer patients whose previous treatment didn't work. The new drugs aim to block two pathways that help cancer grow, potentially making the treatment more effective.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Squamous NSCLC, Brain Metastases, Cardiac Diseases, Others
Must Be Taking:Osimertinib
324 Participants Needed
Relacorilant + Nab-Paclitaxel for Ovarian Cancer
New Brunswick, New Jersey
This trial tests a new combination of two drugs for ovarian cancer patients who have no other treatment options left. The combination includes a drug that may make chemotherapy more effective and a chemotherapy drug that has been used in various cancer treatments. The goal is to see if this combination can help patients live longer without their disease getting worse.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, CNS Metastases, Others
Must Not Be Taking:Corticosteroids, Mifepristone, CYP3A Modulators
381 Participants Needed
Herceptin Hylecta or Phesgo + Chemotherapy for Uterine Cancer
New Brunswick, New Jersey
This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta \[TM\]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo \[TM\]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Cardiovascular Disease, Lung Disease, Others
Must Not Be Taking:CYP2C8, CYP3A4
360 Participants Needed
Belzutifan + Pembrolizumab for Kidney Cancer
New Brunswick, New Jersey
This trial is testing a new treatment in patients who have had kidney cancer surgery. The goal is to see if this treatment can prevent the cancer from coming back. One part of the treatment stops cancer cells from surviving in low oxygen, and the other part helps the immune system attack the cancer. This approach has shown improved survival rates in treating advanced kidney cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Brain Metastases, Others
Must Not Be Taking:Steroids, Immunosuppressive Drugs
1800 Participants Needed
Dato-DXd + Pembrolizumab for Advanced Lung Cancer
New Brunswick, New Jersey
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior NSCLC Treatment, CNS Metastases, Others
Must Not Be Taking:Topoisomerase Inhibitors, TROP2 Therapies
740 Participants Needed
Immunotherapy Combo for Lung Cancer
East Brunswick, New Jersey
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Malignancy, Pneumonitis, Autoimmune Disorders, Others
Must Not Be Taking:Immunosuppressants
860 Participants Needed
177Lu-PSMA-I&T for Prostate Cancer
New Brunswick, New Jersey
This trial is testing a new radioactive drug against standard hormone therapy in men with advanced prostate cancer that doesn't respond to usual treatments. The drug targets and kills cancer cells using radiation. The drug being tested, 225Ac-PSMA-617, has shown promise in inducing complete responses in patients with metastatic castrate-resistant prostate cancer who were resistant to standard therapies.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Chemotherapy, ECOG PS ≥ 2, Others
Must Be Taking:ARAT Therapy
439 Participants Needed
Chemotherapy Tailored by ctDNA Status for Colon Cancer
New Brunswick, New Jersey
This trial tests if a blood test for cancer DNA can help decide if colon cancer patients need more treatment after surgery. The test looks for cancer DNA in the blood to predict if the cancer might come back and to guide further treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Chemotherapy, Others
Must Not Be Taking:Antidepressants, Anticonvulsants
1912 Participants Needed
Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis
New Brunswick, New Jersey
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Other Neurologic Disorders, Uncontrolled Somatic Diseases, Severe Cardiac Disease, Others
188 Participants Needed
Trastuzumab Deruxtecan for Early Stage Breast Cancer
East Brunswick, New Jersey
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Invasive Breast Cancer, Stage IV, ILD/pneumonitis, Others
Must Not Be Taking:Anthracyclines, Cyclophosphamide, Taxanes
927 Participants Needed
Combination Immunotherapy for Lung Cancer
Voorhees Township, New Jersey
This trial is testing a new combination of treatments for patients with advanced lung cancer. The treatments aim to boost the immune system's ability to fight cancer and prevent it from growing. The goal is to see if this combination can help patients live longer compared to standard treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Organ Transplant, Pneumonitis, Cardiac Disease, Others
Must Not Be Taking:Anti-CTLA4, Immunosuppressives
82 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"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'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
"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
"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
Lomustine + Standard Therapy for Glioblastoma
New Brunswick, New Jersey
This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Malignancy, Others
Must Not Be Taking:Antidepressants, Immunotherapy, Others
306 Participants Needed
Nemvaleukin + Pembrolizumab for Ovarian Cancer
New Brunswick, New Jersey
This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Primary Platinum-refractory, Mucinous Subtype, Others
Must Not Be Taking:IL-2, IL-15, Anti-PD1/PD-L1
456 Participants Needed
Staccato Alprazolam for Epilepsy
New Brunswick, New Jersey
This trial tests if inhaling Staccato alprazolam can quickly stop seizures and prevent them from coming back. It targets patients who need fast-acting seizure control. Staccato alprazolam is a potential therapy for rapid epileptic seizure termination, delivered via a breath-actuated device for rapid systemic exposure.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Alcohol Use Disorder, Atrial Fibrillation, Chronic Pulmonary Disorder, Others
Must Be Taking:Antiseizure Medications
350 Participants Needed
Staccato Alprazolam for Seizures
New Brunswick, New Jersey
This trial is studying the long-term safety and tolerability of Staccato alprazolam, a fast-acting inhaled medication for anxiety and panic disorders. Staccato alprazolam is a fast-acting inhaled formulation of alprazolam, which has been widely used and studied for its efficacy in treating anxiety and panic disorders.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Alcohol/drug Use Disorder, Airway Hypersensitivity, Chronic Pulmonary Disorder, Others
Must Be Taking:Staccato Alprazolam
300 Participants Needed
Hormone Therapy + Radiation for Prostate Cancer
Voorhees Township, New Jersey
This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Malignancy, Others
Must Not Be Taking:Hormonal Therapy, Anti-androgens
2050 Participants Needed
Trastuzumab Deruxtecan for Non-Small Cell Lung Cancer
New Brunswick, New Jersey
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Egfr Mutations, Brain Metastases, Autoimmune Disorders, Myocardial Infarction, Others
450 Participants Needed
Inclisiran for Cardiovascular Disease
Somerset, New Jersey
This trial is testing inclisiran, an injectable drug, on people with heart disease who are already on strong cholesterol-lowering medications. The goal is to see if inclisiran can further reduce the risk of heart attacks and strokes by lowering bad cholesterol levels. Participants will receive the injection periodically. Inclisiran works by significantly reducing bad cholesterol levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Heart Failure, Active Liver Disease, Others
Must Be Taking:High-intensity Statins
17004 Participants Needed
AMX0035 for ALS
New Brunswick, New Jersey
The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Tracheostomy, Renal Insufficiency, Heart Failure, Others
Must Be Taking:Riluzole, Edaravone
664 Participants Needed
Combination Chemotherapy for Rhabdomyosarcoma
New Brunswick, New Jersey
This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 50
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infection, CNS Involvement, Others
Must Not Be Taking:CYP3A4 Inhibitors, Inducers
118 Participants Needed
Amivantamab + Lazertinib + Chemotherapy for Non-Small Cell Lung Cancer
East Brunswick, New Jersey
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Leptomeningeal Disease, Cardiovascular Disease, Others
Must Be Taking:Osimertinib
776 Participants Needed
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