Actively Recruiting
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Led by AstraZeneca · Updated on 2026-03-30
600
Participants Needed
23
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Scheduled to start first-line treatment with tremelimumab, durvalumab, and platinum-based chemotherapy according to current guidelines
- Histologically or cytologically confirmed diagnosis of non-squamous metastatic non-small cell lung cancer, including large cell neuroendocrine carcinoma if considered NSCLC-like
- No sensitizing EGFR mutations or ALK alterations
- Molecular Next Generation Sequencing panel including KRAS, STK11, KEAP1, and TP53 has been initiated
- TTF-1 expression analysis has been initiated
- PD-L1 expression analysis has been initiated
- Women of childbearing potential must use effective contraception during treatment and for at least 3 months after last dose of durvalumab
- Ability to understand the study concept
- Signed informed consent provided according to local regulations
You will not qualify if you...
- Current participation in interventional clinical trials
- Contraindications to treatment according to current guidelines
- Any active tumor other than metastatic non-small cell lung cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 23 locations
1
Research Site
Bad Homburg, Germany
Actively Recruiting
2
Research Site
Berlin, Germany
Actively Recruiting
3
Research Site
Celle, Germany
Withdrawn
4
Research Site
Chemnitz, Germany
Actively Recruiting
5
Research Site
Frankfurt, Germany
Actively Recruiting
6
Research Site
Georgsmarienhütte, Germany
Actively Recruiting
7
Research Site
Gera, Germany
Withdrawn
8
Research Site
Goslar, Germany
Actively Recruiting
9
Research Site
Halle-Dolau, Germany
Actively Recruiting
10
Research Site
Hanover, Germany
Actively Recruiting
11
Research Site
Herne, Germany
Actively Recruiting
12
Research Site
Koln-Mehrheim, Germany
Actively Recruiting
13
Research Site
Mainz, Germany
Actively Recruiting
14
Research Site
Marburg, Germany
Actively Recruiting
15
Research Site
Münnerstadt, Germany
Actively Recruiting
16
Research Site
Neuss, Germany
Actively Recruiting
17
Research Site
Offenbach, Germany
Actively Recruiting
18
Research Site
Ravensburg, Germany
Actively Recruiting
19
Research Site
Rüsselsheim am Main, Germany
Actively Recruiting
20
Research Site
Treuenbrietzen, Germany
Actively Recruiting
21
Research Site
Ulm, Germany
Actively Recruiting
22
Research Site
Wiesbaden, Germany
Actively Recruiting
23
Research Site
Zwickau, Germany
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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