Study of Tremelimumab, Durvalumab, and Platinum Chemotherapy Effectiveness in Adults with Metastatic Non-squamous Non-Small Cell Lung Cancer and High-Risk Genetic Changes

What this Trial Is About

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.

NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations