Kostroma

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

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.