SUNRAY-01 A Global Pivotal Study in Participants with KRAS G12C-Mutant Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing FirstLine Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression =50% or LY3537982 and Pembrolizumab Pemetrexed Platinum vs Placebo and Pembrolizumab Pemetrexed Platinum regardless of PD-L1 Expression
This study is testing two different treatments (LY3537982 in combination with pembrolizumab against a placebo combined with pembrolizumab) for a cancer called KRAS G12C-mutant NSCLC (non-small cell lung cancer). The study has two parts: Part A compares the treatments with one another for patients whose cancer has a marker called PD-L1 at a level of 50% or higher. Part B looks at the same treatments for patients with PD-L1 ranging from 0 to 100%. The decision about which part a patient joins depends on their doctor and what's best for treatment. Before joining, some patients might get one cycle of regular treatment if they really need it. The study also has two different doses of LY3537982 in combination with pembrolizumab, and they're trying to figure out the best amount, comparing different options to see which one works better. Overall, the study team is hoping to find better treatments for this type of lung cancer.
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. At least 500 eligible patients will be randomized 3:1 to trastuzumab emtansine (T-DM1), followed by subcutaneous (SC) trastuzumab (Herceptin Hylecta) (n = 375) or paclitaxel plus trastuzumab SC (TH) (n = 125). Patients may have any hormone receptor status, may be either pre- or post-menopausal, and must be systemic treatment-naïve for this cancer. HER-2 positivity will be confirmed by central testing in all patients. Patients will bestratified by Age (
A Phase 1a/1b Open-Label Study Evaluating the Safety Tolerability Pharmacokinetics and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study
This is a Phase 1 study testing whether the new medicine BBO-8520 (a KRASG12C on/off inhibitor) is a safe and effective treatment option if given alone or together with another medicine called pembrolizumab (immunotherapy) for lung cancer patients whose tumors show changes in the KRAS gene. The study consist of two parts. In part 1, patients will be enrolled into one of five groups to receive the study medicine BBO-8520 alone. The study team will gradually increase the dose level of the study medicine for each group to find out the effective dose with fewer side effects. Some patients will be grouped to receive study medicine BBO-8520 together with pembrolizumab. In part 2, more patients will be included to receive the dose that was found to be effective while being safe. Patients who have previously received approved KRAS G12C inhibitors (ie, sotorasib and adagrasib) will be eligible. All patients will have blood samples taken to see how their bodies are handling the study medicines. The study team will have imaging scans taken for all patients to see how the study medicine is changing their tumor size. All patients will be closely monitored for side effects and safety concerns.
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician s choice chemotherapy compared to trastuzumab in combination with physician s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment
This study tests a new treatment called zanidatamab against a standard treatment called trastuzumab. Both treatments will be given with chemotherapy chosen by the doctor for patients with metastatic HER2-positive breast cancer who have not done well on or cannot tolerate a previous treatment called T-DXd. To join the study, patients need to have had at least two lines of HER2-directed therapies before. Patients will be checked for HER2-positive status before being enrolled, and randomization will happen once they meet all the study criteria. Patients will be assigned randomly to one of the two treatments, with groups based on their past treatments and where they live. They will receive their treatment in 21-day cycles until their disease gets worse, they decide to leave the study, or other reasons to stop occur. The study will keep a close watch on how effective the treatments are, with patients getting regular scans to check their health.
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Ultrasound Unit—OB/GYN | NYU Langone Health
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