Massillon

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are evaluating the safety and effectiveness of a new antibody drug called gotistobart (ONC-392/BNT316) compared to the chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has worsened after treatment with PD-1 or PD-L1 inhibitors. This Phase 3 clinical trial aims to see if gotistobart can help patients live longer than with standard chemotherapy. The study will enroll about 630 patients who have squamous cell NSCLC and have shown disease progression on prior immunotherapy. The trial has two stages. In Stage I, two different dosing regimens of gotistobart will be tested against docetaxel to confirm the best dose. Gotistobart is given through a 60-minute intravenous infusion every 21 days at either 3 mg/kg or 6 mg/kg (with two initial loading doses of 10 mg/kg). Docetaxel is given by IV infusion every 21 days at 75 mg/m2. Stage II will compare the chosen gotistobart dose to docetaxel in patients with squamous NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will undergo tumor measurements to confirm disease progression and meet health criteria such as organ function and performance status. Researchers will monitor overall survival over 36 months as the main outcome. Safety and side effects will be closely followed. The study requires patients to have recovered from prior treatment effects and have no active infections or serious heart or lung disease. Through this trial, researchers hope to determine whether gotistobart is a beneficial treatment option for this group of lung cancer patients.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are collecting real-world clinical and patient-reported data from cancer patients using an electronic care planning system with remote symptom monitoring. This study focuses on patients with breast, lung, ovarian cancer, multiple myeloma, or acute myelogenous leukemia who are actively receiving treatment. The aim is to build a data set to enhance Carevive's registry by gathering information through routine care. Participants complete a baseline survey either in person using a secure device or remotely on their own electronic device. Following this, they receive weekly online surveys via the Carevive platform to report symptoms and outcomes for at least 12 weeks. Patients may continue these weekly surveys for as long as they remain on treatment. During the study, participants regularly provide information through electronic surveys that capture their treatment experiences and symptom changes. This data is securely collected to monitor ongoing patient outcomes. The primary outcome is the creation of a comprehensive data set over one year, reflecting real-world treatment experiences and symptom monitoring during active cancer therapy.

Researchers are evaluating the safety and effectiveness of adding sacituzumab tirumotecan to pembrolizumab compared to the treatment of physician's choice in adults with triple-negative breast cancer (TNBC) who received neoadjuvant therapy but did not achieve a complete response after surgery. This Phase 3, randomized, open-label study aims to determine if the combination improves invasive disease-free survival (iDFS) over other approved treatments. The study focuses on participants who have residual disease after surgery and have recovered sufficiently to continue treatment. Participants receive either sacituzumab tirumotecan 4 mg/kg intravenously every two weeks combined with pembrolizumab 400 mg intravenously every six weeks, or treatment chosen by their physician, which may include pembrolizumab alone or pembrolizumab with oral capecitabine taken twice daily. Treatment is given after surgery and any indicated radiation therapy, with randomization occurring within 16 weeks post-surgery. The study monitors participants for up to about 77 months to assess long-term outcomes. During the study, participants undergo regular assessments including clinical evaluations and monitoring for disease recurrence, side effects, and overall health. Tissue samples collected at surgery are analyzed for biomarkers like TROP2. Safety is closely monitored, and participants must have good performance status to join. The study collects data on how long participants remain disease-free and tracks any adverse events to understand treatment effects over the extended follow-up period.