Lafayette

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating HB0036 in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), in a Phase I/II, open-label, multicenter study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of HB0036. Phase I focuses on safety and tolerability in patients with advanced solid tumors who have exhausted standard treatments. Phase II evaluates the safety and efficacy of HB0036 at a recommended dose in patients with NSCLC and other solid tumors, with a Safety Review Committee monitoring treatment safety throughout the study. Participants receive fixed doses of HB0036 administered intravenously every three weeks. Dose regimens are assigned in order of enrollment. Phase I involves dose escalation to find safe dosing, while Phase II includes cohorts with specific tumor types such as NSCLC and melanoma. Tumor samples are collected to confirm eligibility and PD-L1 expression for NSCLC patients. The study allows adjustments to dosing and frequency based on safety findings. Participants undergo various assessments including tumor imaging by CT or MRI to measure lesions, laboratory tests for organ function, and pregnancy tests for women of childbearing potential. Safety and tolerability are monitored for up to 12 months, and the maximum tolerated dose is assessed up to 24 months. Researchers also track adverse events and patient performance status. The total participation duration depends on treatment response and safety outcomes.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of INV-1120, a selective small molecule drug, alone and combined with pembrolizumab in adults with advanced solid tumors. This Phase 1, open-label dose-escalation study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as the dose-limiting toxicities (DLTs) of these treatments. The study includes patients with various solid cancers that have progressed after standard therapy or for which no standard treatment exists. In Phase 1a, about 36 patients will receive INV-1120 alone to find the MTD and RP2D, with up to 9 additional patients enrolled to confirm safety at the chosen dose. In Phase 1b, approximately 36 to 42 patients will receive combinations of INV-1120 and pembrolizumab, given as 200 mg on Day 1 of each 3-week cycle, to identify the RP2D and DLTs of the combination. Selected combination doses will be expanded to 12-15 patients to further assess safety and tolerability. Participants will undergo regular monitoring including imaging with CT or MRI to measure tumor lesions and laboratory tests to assess organ function. Women of childbearing potential must have a negative pregnancy test and both male and female participants must use effective contraception. Researchers will track treatment responses, side effects, and drug levels during the study, which spans up to 12 months for each phase to evaluate safety, tolerability, and early antitumor activity.

Researchers are evaluating the safety and effectiveness of the coflex4 Interlaminar Technology compared to decompression surgery alone in adults with degenerative spinal stenosis and associated low back pain. This study is a prospective, multi-center trial with concurrent enrollment and a propensity score control, designed to fully characterize clinical outcomes under actual conditions of use, with follow-up evaluations at 2 and 5 years. Participants receive either decompression surgery plus the coflex4 device or decompression surgery alone. The study compares the performance of the coflex device to prior investigational device exemption (IDE) data at 24 and 60 months and to decompression alone from the ESCADA study at 24 months. The treatment focuses on surgical decompression of one or two lumbar levels (L1-L5) with or without additional stabilization using the coflex technology. During the study, participants undergo clinical assessments including pain and disability questionnaires, with measurements such as the Visual Analog Scale for back pain and the Oswestry Low Back Pain Disability Questionnaire. Researchers monitor clinical success and safety outcomes over the extended follow-up period. Participants must comply with scheduled visits and study procedures throughout the duration, including informed consent and psychosocial, mental, and physical ability to adhere to the protocol.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the impact of spiritual care on patients with advanced stage IV lung and gastrointestinal cancers. This study aims to understand how spiritual care influences spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and the quality of communication. The trial compares a chaplain-led spiritual care intervention with an attention control group receiving informational support, addressing the need for effective spiritual support in this patient population. Participants are randomly assigned to one of two groups: the spiritual care intervention or the informational support comparator. The spiritual care group receives four weekly sessions led by a board-certified or board-eligible chaplain focusing on topics like meaning and purpose, relationships, transcendence and peace, and self-worth and identity. The informational support group also attends four weekly sessions with a trained social worker covering quality of life, financial resources, and health information evaluation. During the study, participants attend approximately weekly visits over about four weeks. Researchers assess the feasibility and acceptability of the spiritual care framework compared to informational support during these visits and through a survey one week after the intervention. Spiritual wellbeing is measured at 1, 6, and 12 weeks after the intervention. Participants' cognitive function and ability to engage in the sessions are monitored, and their health status and spiritual wellbeing are evaluated throughout the study.

Researchers are studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.