Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494540
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-20
Brief Title:
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Prospective Non-interventional Study NIS to Examine the Effectiveness of Tremelimumab Durvalumab Platinum Chemotherapy TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAUTIC
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 Serinethreonine 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None