NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Recruiting · NCT06494540 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →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.
Who can take part
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
Where it is running
30 locations listed.
- Research Site - Bad Homburg, Germany
- Research Site - Berlin, Germany
- Research Site - Bremen, Germany
- Research Site - Celle, Germany
- Research Site - Chemnitz, Germany
- Research Site - Cologne, Germany
- Research Site - Deggendorf, Germany
- Research Site - Frankfurt, Germany
- Research Site - Georgsmarienhütte, Germany
- Research Site - Gera, Germany
- Research Site - Goslar, Germany
- Research Site - Greifswald, Germany
- Research Site - Halle-Dolau, Germany
- Research Site - Hanover, Germany
- Research Site - Herne, Germany
- Research Site - Hösbach, Germany
- Research Site - Koblenz, Germany
- Research Site - Koln-Mehrheim, Germany
- Research Site - Mainz, Germany
- Research Site - Marburg, Germany
- Research Site - Münnerstadt, Germany
- Research Site - Neuss, Germany
- Research Site - Offenbach, Germany
- Research Site - Querfurt, Germany
- Research Site - Ravensburg, Germany
- Research Site - Rüsselsheim am Main, Germany
- Research Site - Treuenbrietzen, Germany
- Research Site - Ulm, Germany
- Research Site - Wiesbaden, Germany
- Research Site - Zwickau, Germany