RecruitingNCT06494540

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


Sponsor

AstraZeneca

Enrollment

600 participants

Start Date

Jun 28, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking how well a combination immunotherapy regimen (tislelizumab, deruxtecan, and carboplatin, known as TDC) works in real-world patients with metastatic non-squamous non-small cell lung cancer that carries certain high-risk genetic changes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic non-squamous non-small cell lung cancer confirmed by biopsy - Your doctor has already decided to start you on TDC treatment based on standard guidelines - Your tumor has been tested for EGFR mutations, ALK changes, and other genes (KRAS, STK11, KEAP1, TP53) - Your tumor does not have sensitizing EGFR mutations or ALK alterations **You may NOT be eligible if...** - You have EGFR mutations or ALK alterations (you would receive different targeted therapy) - Your tumor has not been molecularly tested - You are being enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(23)

Research Site

Bad Homburg, Germany

Research Site

Berlin, Germany

Research Site

Celle, Germany

Research Site

Chemnitz, Germany

Research Site

Frankfurt, Germany

Research Site

Georgsmarienhütte, Germany

Research Site

Gera, Germany

Research Site

Goslar, Germany

Research Site

Halle-Dolau, Germany

Research Site

Hanover, Germany

Research Site

Herne, 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

Ravensburg, Germany

Research Site

Rüsselsheim am Main, Germany

Research Site

Treuenbrietzen, Germany

Research Site

Ulm, Germany

Research Site

Wiesbaden, Germany

Research Site

Zwickau, Germany

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NCT06494540