Anderlecht

Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system CNS metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA ctDNA from cerebrospinal fluid CSF samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods before the first CNS event Part A, at the first CNS diagnosis Part B, and after the first CNS event Part C. Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participants cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are comparing INCA033989 with the best available therapy for adults who have essential thrombocythemia ET with a CALR mutation and have previously received cytoreductive treatment. The study aims to evaluate the effects of these treatments on this specific patient group. It is a Phase 3 clinical trial sponsored by Incyte Corporation to assess treatment responses and safety. Participants will be randomly assigned to receive either INCA033989 administered intravenously or the best available therapy chosen by their doctor. The treatments are given according to the study protocol. The study focuses on treatment outcomes over a period of weeks, including response durability and symptom changes, with assessments at specified timepoints. During the study, participants will have regular visits to monitor their clinical and hematologic responses, symptoms, and any side effects. Researchers will collect data on mutation levels, symptom questionnaires, and fatigue assessments up to 48 weeks. Safety monitoring will continue for 60 days following the last dose. The total duration of participation may extend up to several months as outlined by the trial schedule.

Researchers are evaluating AZD8205, a new antibody drug conjugate, as a possible treatment for advanced or metastatic solid tumors including breast cancer, biliary tract cancer, ovarian, endometrial, and squamous non-small cell lung cancers. This Phase IIIa multi-center, open-label study aims to determine the safety, tolerability, and appropriate dosing of AZD8205 alone or combined with other anticancer agents such as rilvegostomig, saruparib, and AZD9574. The study includes dose escalation and expansion parts to assess anti-tumor activity in select solid tumors. Participants are assigned to one of four sub-studies that involve different combinations of AZD8205 with other drugs. Each sub-study has two parts Part A focuses on dose escalation to find safe doses, and Part B evaluates the anti-tumor effects at the recommended doses. Some sub-studies may add triplet combinations based on safety data and may include future protocol amendments. Treatment is given according to the assigned sub-study and dosing schedules. During the study, participants undergo assessments including monitoring for adverse events, serious adverse events, dose-limiting toxicities, and changes in laboratory tests, ECGs, and vital signs. Researchers also measure responses such as objective response rate, duration of response, progression-free survival, disease control rate, overall survival, pharmacokinetics, and immunogenicity over approximately two years. Study participation includes regular visits for treatment and evaluations, with safety follow-up until 30 days after the last dose.

Researchers are evaluating the safety and effectiveness of new drug combinations, including rilvegostomig with standard platinum-based chemotherapy, with or without ramucirumab, for treating advanced or metastatic non-small cell lung cancer NSCLC. This study is open-label and multicenter, involving participants with confirmed stage IV NSCLC. It includes a sub-study with safety run-in and expansion parts to find the best dose and assess treatment activity. Participants receive treatments infused intravenously, including rilvegostomig, ramucirumab, and chemotherapy drugs like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Non-squamous NSCLC participants are randomly assigned to either rilvegostomig plus chemotherapy with ramucirumab or rilvegostomig plus chemotherapy alone, while squamous NSCLC participants receive rilvegostomig plus chemotherapy and ramucirumab. The study includes initial safety evaluation and dose expansion phases. During the study, participants undergo tumor tissue collection, disease measurements, and regular assessments of side effects, tumor response, and survival. Researchers monitor blood samples for drug levels and antibodies and track progression and overall survival over approximately 46 months. Safety, tolerability, and anti-tumor effects are closely followed throughout the treatment and observation periods.

This research aims to observe the real-world use and effects of pegcetacoplan in adults diagnosed with Paroxysmal Nocturnal Hemoglobinuria PNH. As a new treatment with a unique mechanism of action, pegcetacoplans effectiveness and safety in routine medical practice are being studied to provide valuable information for patients, healthcare providers, and payers. The study will also gather data on blood transfusions and healthcare resource use before and after starting pegcetacoplan. Patients who have started pegcetacoplan treatment within the past 12 months or are prescribed the drug at enrollment will be included. Data collection includes retrospective information from up to 12 months before treatment start and prospective monitoring for approximately 36 months, with the total data period extending up to about 48 months. After stopping pegcetacoplan, patients remain in the study for 8 weeks to record any adverse events. Patients continue regular clinic visits, where data from each visit will be gathered. Participants will have data collected on various health measures such as hemoglobin levels, blood markers, transfusion needs, and patient and physician treatment satisfaction at regular intervals up to 36 months. Safety and adverse events will be monitored throughout. The main outcome measured is the change in hemoglobin level from treatment start to 6 months. This long-term observational study allows for comprehensive tracking of pegcetacoplans use and effects over time in usual care settings.

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

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 treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.

Researchers are evaluating how long adult participants with KRASNRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer remain disease-free when treated with different combinations of drugs. The study compares amivantamab combined with chemotherapy regimens mFOLFOX6 or FOLFIRI versus cetuximab combined with the same chemotherapy regimens. This phase 3 trial aims to understand which treatment approach may better delay cancer progression. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles consisting of 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin or irinotecan hydrochloride, repeated every 28 days. The other group receives cetuximab combined with the same chemotherapy regimens, also in 28-day cycles. Treatments continue until imaging shows disease progression or other criteria require stopping. During the study, participants will undergo regular assessments including radiographic imaging to monitor disease status and treatment effects. Researchers will measure progression-free survival for up to over 4 years, along with other outcomes such as overall survival, response rates, duration and time to response, and quality of life using validated questionnaires. Safety will be monitored through adverse event reporting and laboratory tests, with follow-up continuing for several years to capture long-term results.