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193 Clinical Trials near Bloomfield, 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 PowerSubcutaneous Anifrolumab for Lupus
Newark, New Jersey
This trial is testing an injectable medication called anifrolumab in adults with moderate-to-severe lupus who haven't fully responded to standard treatments. Anifrolumab works by reducing the immune system's attack on the body to help lessen lupus symptoms. It has been approved for the treatment of moderate to severe systemic lupus erythematosus (SLE) based on evidence from various studies.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Neuropsychiatric SLE, Severe Renal Disease, Recurrent Infections, HIV, Hepatitis, Cancer, Others
Must Be Taking:DMARDs, Glucocorticoids, Antimalarials
367 Participants Needed
Talazoparib + Enzalutamide for Metastatic Prostate Cancer
Belleville, New Jersey
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
MRTX849 + Cetuximab for Colorectal Cancer
Belleville, New Jersey
This trial is testing a new treatment for patients with colorectal cancer. The treatment combines two drugs that work together to block cancer growth and prevent its spread. One of the drugs has shown promise in treating other types of cancer as well.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Brain Metastasis, Others
Must Not Be Taking:KRAS Inhibitors, Anti-EGFR
461 Participants Needed
Pegcetacoplan for Age-Related Macular Degeneration
Bloomfield, New Jersey
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
OPT-302 + Ranibizumab for Age-Related Macular Degeneration
Bloomfield, New Jersey
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Not Listed
990 Participants Needed
T-DM1 + Tucatinib for Breast Cancer
Newark, New Jersey
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Cancer, Hepatitis B/C, Others
Must Be Taking:Taxane, Trastuzumab
1056 Participants Needed
Long-Term Safety of Linaclotide for Constipation
East Orange, New Jersey
This trial tests linaclotide, a medication that helps relieve constipation by increasing fluid in the intestines, in children aged 6-17 with constipation issues. Linaclotide is approved for treating certain types of constipation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 18
Key Eligibility Criteria
Disqualifiers:Down's Syndrome, Celiac Disease, Inflammatory Bowel Disease, Others
Must Not Be Taking:Cocaine, Barbiturates, Opiates, Cannabinoids
389 Participants Needed
Darolutamide + Standard Therapy for Prostate Cancer
Clifton, New Jersey
This trial is testing darolutamide, a new drug added to standard hormone therapy, in men with high-risk localized prostate cancer undergoing radiation. The goal is to see if this combination can better prevent the cancer from coming back and spreading compared to current treatments. Darolutamide works by blocking male hormones that help cancer grow, potentially reducing death rates from prostate cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, PSA > 100, Others
Must Be Taking:LHRHA
1100 Participants Needed
Apalutamide + Hormone and Radiation Therapies for Prostate Cancer
Newark, New Jersey
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Seizure History, Cardiac Disease, Others
Must Be Taking:GnRH Agonist/antagonist
586 Participants Needed
Nivolumab + Ipilimumab for Liver Cancer
Newark, New Jersey
This trial is testing a combination of two drugs, nivolumab and ipilimumab, which help the immune system fight cancer. It targets patients with advanced liver cancer who haven't received any previous whole-body treatments. The goal is to see if these drugs can help patients live longer compared to standard treatments. Nivolumab and ipilimumab have been used in combination to treat various advanced cancers, showing promising results but with higher side effects compared to using a single drug.
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:Fibrolamellar HCC, Liver Transplant, Others
732 Participants Needed
PF-06651600 for Alopecia Areata
Verona, New Jersey
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.
A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Hearing Loss, Malignancies, Herpes, Infection, Others
Must Not Be Taking:JAK Inhibitors
1052 Participants Needed
Tucatinib + T-DM1 for Breast Cancer
West Orange, New Jersey
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
Immunotherapy + Chemotherapy for Hodgkin's Lymphoma
Newark, New Jersey
This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, 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. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Organ Transplant, CNS Lymphoma, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
994 Participants Needed
CTP-543 for Alopecia Areata
Verona, New Jersey
This trial is testing CTP-543, a medication that may help people regrow hair by stopping the immune system from attacking hair follicles. It focuses on adults with chronic, moderate to severe alopecia areata. CTP-543 has shown promise in treating this condition.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Scalp Inflammation, Psoriasis, Pregnancy, Others
1000 Participants Needed
Long-term Safety and Efficacy of Bimatoprost SR for Glaucoma
Newark, New Jersey
This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Other Drug Studies, Others
Must Be Taking:Bimatoprost SR
455 Participants Needed
Pembrolizumab + Radiotherapy for Head and Neck Cancer
Newark, New Jersey
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
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:Metastases, Immunodeficiency, Autoimmune, Others
Must Not Be Taking:Immunosuppressants, Steroids, Live Vaccines, Others
714 Participants Needed
Upadacitinib for Eczema
Clifton, New Jersey
This trial is testing upadacitinib, an oral medication, to see if it can help people with severe eczema. The medication works by calming down the overactive immune system to reduce skin inflammation and itching. Upadacitinib is approved in many countries for the treatment of atopic dermatitis in individuals whose disease is not adequately controlled with other treatments or when those treatments are not suitable.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 75
Key Eligibility Criteria
Disqualifiers:Other Skin Diseases, Pregnancy, Others
Must Not Be Taking:JAK Inhibitors
912 Participants Needed
Hypofractionated Radiation Therapy for Breast Cancer
Newark, New Jersey
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metaplastic Breast Cancer, T4, N3, Others
897 Participants Needed
Talazoparib + Enzalutamide for Prostate Cancer
Nutley, New Jersey
This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Renal Dysfunction, Hepatic Dysfunction, Brain Metastasis, Others
Must Not Be Taking:Opioids, P-gp Inhibitors
1054 Participants Needed
HAV vs AVF for Hemodialysis Access
Newark, New Jersey
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Peripheral Arterial Disease, Cancer, Others
Must Not Be Taking:Immunosuppressants, Cytotoxic Agents
240 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
"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
"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 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 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
Abemaciclib + Endocrine Therapy for Breast Cancer
Newark, New Jersey
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Inflammatory Breast Cancer, Others
Must Be Taking:Endocrine Therapy
5637 Participants Needed
Human Acellular Vessel for Vascular Trauma
Newark, New Jersey
This trial tests a special type of blood vessel called a Human Acellular Vessel (HAV) in adults with serious blood vessel injuries below the neck. The HAV is used to replace or bypass damaged vessels, helping restore blood flow. The study will follow patients for several years after the procedure. The Human Acellular Vessel (HAV) is a bioengineered conduit developed by Humacyte, Inc., known for its off-the-shelf availability and resistance to infection, making it ideal for complex revascularization scenarios.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Injuries, Amputation Risk, Others
Must Be Taking:Antiplatelets
72 Participants Needed
Pembrolizumab for Triple-Negative Breast Cancer
Newark, New Jersey
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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:Metastatic Disease, Active Autoimmune, Others
Must Not Be Taking:Immunotherapy, Biologic Therapy
1155 Participants Needed
Chemotherapy for Acute Lymphoblastic Leukemia
Newark, New Jersey
This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:1 - 31
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, BCR-ABL1, Others
Must Not Be Taking:CYP3A4/5 Inducers
5949 Participants Needed
Nivolumab +/- Ipilimumab for Lung Cancer
Newark, New Jersey
This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.
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:Autoimmune Disease, Hepatitis, HIV, Others
Must Not Be Taking:Corticosteroids, Immunosuppressives
275 Participants Needed
Weight Loss Intervention for Breast Cancer Recurrence Prevention
Newark, New Jersey
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Cardiovascular, Psychiatric Disorders, Others
Must Be Taking:Hormonal Therapy
3177 Participants Needed
Injectable Cabotegravir for HIV Prevention
Newark, New Jersey
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Not Listed
4570 Participants Needed
Interferon + Ipilimumab + Pembrolizumab for Melanoma
East Orange, New Jersey
This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Active Infection, Autoimmune Disease, Others
Must Not Be Taking:Immunotherapy, Biologic Therapy
1301 Participants Needed
Triapine + Chemotherapy/Radiation for Cervical and Vaginal Cancers
Newark, New Jersey
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal 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:Active Malignancy, Uncontrolled Illness, Pregnancy, Others
Must Not Be Taking:Antiretrovirals, Investigational Agents
450 Participants Needed
Afatinib +/− Cetuximab for Non-Small Cell Lung Cancer
Newark, New Jersey
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Interstitial Lung Disease, Cardiovascular Abnormalities, Hepatitis, Others
Must Not Be Taking:EGFR Inhibitors
174 Participants Needed
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