Tomaszow Mazowiecki

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the effectiveness and safety of AZD0901 compared to Investigator's choice of therapy for adults with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. This Phase III, global, multi-center, open-label, randomized study also includes an assessment of the Ventana CLDN18.2 assay as a diagnostic tool to identify patients who might benefit from AZD0901 treatment. Participants are randomly assigned to receive either AZD0901 at two different dose levels (with enrollment for the second dose level closed) or Investigator's choice of therapy. The comparator therapies include ramucirumab plus paclitaxel, paclitaxel alone, docetaxel, irinotecan, TAS-102 (oral), or apatinib (oral, China only), with dosing schedules varying by drug. Treatments are given intravenously or orally according to specific regimens and cycles. Participants will be involved in assessments measuring progression-free survival and overall survival for up to about three years from their first dose or randomization. Researchers will monitor disease progression, survival, safety, and the clinical performance of the diagnostic test. The study includes regular evaluations, imaging, and laboratory tests to track treatment effects and participant health throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and early anti-tumor effects of trastuzumab deruxtecan (T-DXd) alone or combined with chemotherapy and/or immunotherapy in adults with HER2-expressing advanced or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. This Phase 1b/2 study tests whether these combinations at the recommended phase 2 dose show manageable safety and promising anti-tumor activity to support further clinical testing. Participants receive T-DXd either as monotherapy or combined with drugs such as fluorouracil (5-FU), capecitabine, durvalumab, oxaliplatin, trastuzumab, cisplatin, pembrolizumab, volrustomig, or rilvegostomig. Most drugs are given by intravenous infusion, except capecitabine which is taken orally. The study includes dose escalation and expansion parts and covers multiple treatment arms based on HER2 status and prior therapy, with treatment details tailored per study part. During the study, participants undergo regular safety assessments including monitoring for adverse events, dose-limiting toxicities, laboratory tests, vital signs, and electrocardiograms up to approximately 24 months. Efficacy is measured by confirmed tumor response per RECIST criteria over about 12 months. Researchers also collect pharmacokinetic and immunogenicity data to understand drug behavior and immune response. This comprehensive monitoring supports evaluation of safety and preliminary effectiveness in this patient population.

Researchers are evaluating the safety and tolerability of trastuzumab deruxtecan (T-DXd) combined with immunotherapy agents, with or without chemotherapy, in patients with HER2 over-expressing non-small cell lung cancer (NSCLC). This Phase Ib study also looks at how effective these combinations may be. The study focuses on patients with advanced or metastatic non-squamous NSCLC who have measurable disease and no known actionable genomic alterations with approved therapies. Patients must have an ECOG performance status of 0 or 1 and be treatment-nave for advanced disease. The study is divided into multiple parts. Part 1 involves dose escalation to assess safety and recommended doses of T-DXd combined with durvalumab and chemotherapy agents (cisplatin, carboplatin, or pemetrexed), but no further patients will be enrolled in this part. Parts 3, 4, and 5 evaluate T-DXd with different immunotherapy agents (volrustomig or rilvegostomig), with or without carboplatin, and explore dose optimization and priming versus flat dosing regimens. Some parts include dose escalation, dose expansion, and optional arms at the sponsor's discretion. Participants will receive study drugs via intravenous infusion and undergo evaluations for safety, tolerability, and response. Researchers will monitor adverse events and serious adverse events for about 20 months from consent to determine the recommended phase 2 dose. Patients will be assessed for measurable disease using RECIST 1.1 criteria, and organ and bone marrow function will be checked. Safety monitoring includes cardiac assessments and screening for infections. The study aims to gather data on tolerability and potential efficacy over the treatment period.

Researchers are evaluating the progression-free survival (PFS) of casdatifan compared to placebo, each given with cabozantinib, in adults with advanced or metastatic clear cell Renal Cell Carcinoma who have experienced disease progression after prior anti-PD-1 or anti-PD-L1 immunotherapy. This is a Phase 3, randomized, double-blind, active-control trial focusing on this patient population. Participants receive treatment with either casdatifan plus cabozantinib or placebo plus cabozantinib as specified in the treatment arms. The study compares these combinations to assess their effects on the cancer. Treatment is administered according to the assigned group throughout the study period. During the study, patients undergo regular evaluations including imaging to measure tumor response by RECIST 1.1 criteria. Progression-free survival is assessed by a central independent review over approximately 33 months. Additional assessments include monitoring of organ and marrow function and safety evaluations. Participants may be followed for long-term safety and efficacy outcomes.