NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
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
- Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- AstraZeneca
- Enrolment target
- 600
- Started
- 28 June 2024
- Main results due
- 31 December 2029
- Study sites
- 30
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 120 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Aged ≥ 18 years * Decision to start first-line (1L) treatment with TDC according to the current SmPCs * Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician) * No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations * Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53) * TTF-1 expression analysis has been initiated * PD-L1 expression analysis has been initiated * Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab * Ability to understand the study concept * Provision of signed informed consent form in accordance with applicable local provisions Exclusion Criteria: * Current participation in interventional clinical trials * Contraindications according to current SmPCs * Any active tumor other than metastatic NSCLC\* * Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component * determined by investigator as likely to influence the prognosis or management of mNSCLC
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(30)
Research Site
Bad Homburg, Germany
Recruiting
Research Site
Berlin, Germany
Recruiting
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Bremen, Germany
Recruiting
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Celle, Germany
Withdrawn
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Chemnitz, Germany
Recruiting
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Cologne, Germany
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Deggendorf, Germany
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Frankfurt, Germany
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Georgsmarienhütte, Germany
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Gera, Germany
Withdrawn
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Goslar, Germany
Recruiting
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Greifswald, Germany
Recruiting
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Halle-Dolau, Germany
Recruiting
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Hanover, Germany
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Herne, Germany
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Hösbach, Germany
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Koblenz, Germany
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Koln-Mehrheim, Germany
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Mainz, Germany
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Marburg, Germany
Recruiting
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Münnerstadt, Germany
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Neuss, Germany
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Offenbach, Germany
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Querfurt, Germany
Recruiting
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Ravensburg, Germany
Recruiting
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Rüsselsheim am Main, Germany
Withdrawn
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Treuenbrietzen, Germany
Recruiting
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Ulm, Germany
Recruiting
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Wiesbaden, Germany
Recruiting
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Zwickau, Germany
Recruiting
Showing 30 of 30 sites. 27 of the 30 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06494540. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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