Hosbach

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are studying how personalized coaching based on patient typology affects therapy persistence in patients with HRHER2- early breast cancer who are taking ribociclib. The study aims to compare the time it takes for patients to permanently stop treatment between those receiving personalized coaching and those who receive only standard care education and counseling. This research focuses on improving adherence to ribociclib therapy. Participants are randomly assigned to one of two groups one group receives personalized therapy coaching tailored to their patient typology using the MASCC Oral Agent Teaching Tool MOATT, and the other group receives standard care patient counseling without additional coaching. The study evaluates behavioral interventions related to therapy management over a period that could extend up to five years. During the study, participants will have scheduled visits and follow the treatment plans and trial procedures as required. Researchers will monitor the time to permanent discontinuation of ribociclib treatment as the primary outcome, with secondary measures including ribociclib persistence rates at 6, 12, and 36 months after therapy begins. Participants are expected to comply with visits and assessments throughout the study duration, which may last up to five years.

Researchers are gathering real-world clinical data from women with primary advanced FIGO stage III or IV or recurrent endometrial cancer who are treated with first-line chemotherapy regimens combining Carboplatin, Paclitaxel, and Durvalumab CPD. This observational study focuses on patients receiving maintenance therapy with durvalumab alone or durvalumab combined with olaparib, depending on their tumors DNA mismatch repair status. The aim is to evaluate treatment outcomes including effectiveness, safety, and patient-reported experiences after chemotherapy. Participants receive first-line CPD chemotherapy followed by maintenance therapy tailored to their tumor characteristics patients with DNA mismatch repair deficient tumors receive durvalumab maintenance, while those with proficient status receive both durvalumab and olaparib maintenance. Treatment decisions are made as part of routine care in collaboration with their doctors, independent of the study. The study observes patients who achieve disease control after chemotherapy, tracking their ongoing treatments according to approved guidelines. During the study, participants complete questionnaires to report their quality of life and health status over time. Researchers monitor time to next treatment and progression-free survival at 12 months, as well as the duration of maintenance therapy and chemotherapy phases, and timing between treatments. Safety and real-world usage of therapies are assessed up to 46 months. The study spans multiple centers in Germany and aims to better understand characteristics of patients benefiting from these treatments in everyday clinical practice.

Researchers are collecting real-world data in Germany to better understand how patients with non-squamous metastatic non-small cell lung cancer NSQ mNSCLC, including certain cases of large cell neuroendocrine carcinoma, respond to a combination of tremelimumab, durvalumab, and platinum-based chemotherapy TDC. The study focuses on the effectiveness of this treatment in relation to specific genetic mutations and protein expressions such as KRAS, STK11, KEAP1, TP53, TTF-1, and PD-L1. This observational study aims to improve knowledge about biomarker-guided treatment strategies for distinct patient subgroups with high medical needs. The study follows patients who are starting first-line treatment with TDC as prescribed by current marketing authorizations. Researchers will observe and record outcomes without altering the treatment plan. The study includes molecular testing such as Next Generation Sequencing for gene mutations and protein expression analyses initiated according to institutional standards. Women who can become pregnant must use effective contraception during and for three months after durvalumab treatment. Participants will be monitored over time for up to two years to assess overall survival rates, treatment responses, progression-free survival, and safety through adverse event collection. Data will be gathered from routine clinical practice visits and medical records. The main measurement is the two-year overall survival rate in the total population and in subgroups with specific gene mutations. This study helps track how well treatments work and their safety in everyday medical settings.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

This clinical trial investigates whether Resilience PRO, a digital tool for remote symptom monitoring, can improve the quality of life for adults diagnosed with cancer who are receiving systemic anticancer treatment. The study compares patients using Resilience PRO plus their usual care to those receiving usual care alone. Resilience PRO is approved by French health authorities and designed to collect patient-reported outcomes electronically. Participants in the intervention group will use the Resilience PRO mobile app, which regularly asks about symptoms and sends alerts to the care team when important symptoms are reported. This allows timely adjustment of care. Both the intervention and control groups will continue to receive their usual cancer treatment and care. The trial is randomized and open-label. Throughout the study, researchers will measure quality of life after 3 months as the primary outcome. They will also evaluate health economics over 12 months and overall survival over 36 months. Participants will be monitored remotely using the app, and the study will assess how symptom monitoring affects their care and well-being over time.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.