Treuenbrietzen

Researchers are collecting real-world data on patients in Germany with non-squamous metastatic non-small cell lung cancer (NSQ mNSCLC), including large cell neuroendocrine carcinoma if considered similar to NSCLC. The study focuses on patients starting first-line treatment with tremelimumab and durvalumab combined with platinum-based chemotherapy (TDC) following approved guidelines. This research aims to understand how genetic mutations such as KRAS, STK11, KEAP1, and TP53, as well as protein expressions like TTF-1 and PD-L1, affect treatment outcomes in routine clinical practice. The study observes patients who are scheduled to begin treatment with TDC without altering their care, as it is a non-interventional study. Data is gathered prospectively from multiple centers to analyze the effectiveness of TDC, especially in patient subgroups with certain high-risk genetic alterations. No experimental treatments are administered as part of the study. Participants will be monitored over time to measure overall survival up to two years after treatment initiation. Researchers will collect information on patient genetics, tumor markers, treatment responses, and survival outcomes. The study also ensures safety by following approved treatment guidelines and requires informed consent. The aim is to gather detailed data to support better biomarker-guided treatment decisions for NSQ mNSCLC.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.