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

NCT06494540

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (30)
  • Bad Homburg, Germany
  • Berlin, Germany
  • Bremen, Germany
  • Celle, Germany
  • Chemnitz, Germany
  • Cologne, Germany
  • Deggendorf, Germany
  • Frankfurt, Germany
  • Georgsmarienhütte, Germany
  • Gera, Germany
  • Goslar, Germany
  • Greifswald, Germany
  • Halle-Dolau, Germany
  • Hanover, Germany
  • Herne, Germany
  • Hösbach, Germany
  • Koblenz, Germany
  • Koln-Mehrheim, Germany
  • Mainz, Germany
  • Marburg, Germany
  • Münnerstadt, Germany
  • Neuss, Germany
  • Offenbach, Germany
  • Querfurt, Germany
  • Ravensburg, Germany
  • Rüsselsheim am Main, Germany
  • Treuenbrietzen, Germany
  • Ulm, Germany
  • Wiesbaden, Germany
  • Zwickau, Germany