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NCT06494540From ClinicalTrials.govRecruiting

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

  • Research Site

    Bremen, Germany

    Recruiting

  • Research Site

    Celle, Germany

    Withdrawn

  • Research Site

    Chemnitz, Germany

    Recruiting

  • Research Site

    Cologne, Germany

    Recruiting

  • Research Site

    Deggendorf, Germany

    Recruiting

  • Research Site

    Frankfurt, Germany

    Recruiting

  • Research Site

    Georgsmarienhütte, Germany

    Recruiting

  • Research Site

    Gera, Germany

    Withdrawn

  • Research Site

    Goslar, Germany

    Recruiting

  • Research Site

    Greifswald, Germany

    Recruiting

  • Research Site

    Halle-Dolau, Germany

    Recruiting

  • Research Site

    Hanover, Germany

    Recruiting

  • Research Site

    Herne, Germany

    Recruiting

  • Research Site

    Hösbach, Germany

    Recruiting

  • Research Site

    Koblenz, Germany

    Recruiting

  • Research Site

    Koln-Mehrheim, Germany

    Recruiting

  • Research Site

    Mainz, Germany

    Recruiting

  • Research Site

    Marburg, Germany

    Recruiting

  • Research Site

    Münnerstadt, Germany

    Recruiting

  • Research Site

    Neuss, Germany

    Recruiting

  • Research Site

    Offenbach, Germany

    Recruiting

  • Research Site

    Querfurt, Germany

    Recruiting

  • Research Site

    Ravensburg, Germany

    Recruiting

  • Research Site

    Rüsselsheim am Main, Germany

    Withdrawn

  • Research Site

    Treuenbrietzen, Germany

    Recruiting

  • Research Site

    Ulm, Germany

    Recruiting

  • Research Site

    Wiesbaden, Germany

    Recruiting

  • Research Site

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