Schenectady

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 3 randomized, double-blind trial aims to assess the efficacy, safety, and tolerability of these treatments in this specific patient population. Participants will receive either adagrasib with pembrolizumab and chemotherapy drugs carboplatin or cisplatin plus pemetrexed, or a placebo combined with pembrolizumab and the same chemotherapy drugs. Dosing schedules are specified but not detailed here, and treatment is given according to the study's protocol. The trial includes a placebo comparator group and uses quadruple masking to maintain blinding. Throughout the study, participants will be monitored for progression-free survival and overall survival for up to seven years. Assessments include imaging scans to measure tumor response, quality of life questionnaires, and monitoring for adverse events related to treatment. Safety evaluations continue for up to 90 days after the last dose. The study duration varies, with extensive follow-up to track treatment outcomes and side effects.

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups: one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy (carboplatin and pemetrexed) given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

Researchers are evaluating the combination of Navlimetostat (BMS-986504), pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in participants with first-line metastatic non-small cell lung cancer (NSCLC) who have a homozygous MTAP deletion. This randomized phase 2/3 study focuses on metastatic NSCLC participants with no prior systemic treatment for metastatic disease and aims to assess clinical benefits of adding Navlimetostat to standard treatments. Participants are assigned to one of several study groups receiving either the combination of BMS-986504, pembrolizumab, and chemotherapy drugs (including cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel) or placebo with pembrolizumab and chemotherapy. Each drug is given at specified doses on specified days. The study uses a quadruple-blind method to compare these treatments over time. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, evaluations of progression-free survival and overall survival up to five years, and monitoring for treatment-related side effects. Researchers will also track the duration and timing of tumor responses and collect safety data up to 90 days after last treatment. The total participation duration may extend up to five years for long-term outcome assessments.

Researchers are evaluating the effectiveness and safety of tezepelumab in children aged 5 to less than 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, randomized, double-blind study aims to compare tezepelumab with a placebo to better understand its impact on asthma control. The study includes a 4 to 6-week screening and run-in period, followed by a 52-week double-blind treatment phase where participants receive either subcutaneous injections of tezepelumab or a matching placebo in a 2:1 ratio. After this, there is a 12-week off-treatment follow-up period for those not continuing. Participants may also opt into a 104-week open-label extension to receive tezepelumab before a final 12-week follow-up. During the study, participants will undergo various assessments including lung function tests, asthma symptom questionnaires, and monitoring of asthma exacerbations. Researchers will track blood markers and medication use, as well as healthcare visits and quality of life measures. Safety will be monitored throughout, including antibody testing and drug levels, with all study periods carefully scheduled for comprehensive evaluation until the study ends.

Researchers are evaluating the use of Extended Reality (XR) technology alongside traditional Vector-based gait rehabilitation for patients undergoing Lower Limb Rehabilitation (LLR). This pilot study aims to determine if adding XR can improve motivation and participation during the lengthy recovery process, which often spans weeks or months. The study is sponsored by the University at Albany and focuses on enhancing therapy methods to potentially shorten recovery time. Participants will receive Vector-based gait training paired with Extended Reality tasks delivered through an XR headset during their therapy sessions. These tasks are designed to be goal-driven and integrated along the Vector track to engage patients in mobility-based exercises. This combined approach is being studied to see if it can better support physical therapists and patients during inpatient rehabilitation. During the two-month study period, participants will be assessed on their gait speed as the primary outcome. Researchers will also evaluate patient motivation, confidence, and satisfaction. The study involves close monitoring of therapy sessions, with data collected to measure how the XR-enhanced treatment impacts recovery. The total participation time aligns with the two-month outcome assessment window, focusing on both physical performance and patient experience.

This research aims to evaluate continuous remote temperature monitoring in cancer patients who are at risk of developing fever and infection due to chemotherapy treatment. The study focuses on whether this monitoring can reduce the number of days patients spend hospitalized, the out-of-pocket costs they might face, and the number of billable medical codes generated. The program compares patients who comply with the remote temperature monitoring to those who do not, to see if compliance is linked to fewer inpatient days. Participants will wear a wearable thermometer device throughout their study participation, allowing 24/7 remote temperature monitoring. Physicians can configure alert thresholds for sustained high temperatures, triggering notifications sent to patients' phones. Participants will receive alerts when their temperature exceeds these limits and will be contacted by remote monitors via text or phone calls when an alert occurs. During the study, patients will be monitored continuously and their temperature data collected. Researchers will measure the average number of inpatient days from enrollment up to 180 days, along with participants' out-of-pocket costs and the number of billing codes generated. The study involves completing surveys, responding to alerts, and using the TempShield app. Safety and compliance will be tracked over a maximum participation period of 180 days after enrollment.