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NCT06494540 · ClinicalTrials.gov record · last posted 2026-08-20

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

Study acronym: NAUTIC
StatusRecruiting
PhaseNot specified
Started2024-06-28
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-21
critical
Primary completion pushed: 2028-06-30 → 2029-12-31
2026-08-21
minor
Completion pushed: 2028-06-30 → 2029-12-31
2026-05-23
minor
Trial sites expanded: 23 → 29 locations
Trial Details
NCT Number NCT06494540
Lead Sponsor AstraZeneca
Conditions Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
Enrollment 600 participants
Start Date 2024-06-28
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20