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Life sciences · Observational Study
ClinicalTrials.gov · September 28, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06494540). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma. Primary outcome measures: Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population , Time from patient's index date until death by any cause, up to 24 months; Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS , Time from patient's index date until death by any cause, up to 24 months; Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11 , Time from patient's index date until death by any cause, up to 24 months. Brief summary: This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine/threonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.