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

Recruitingn/aAges 18 Years - 120 YearsAllAstraZeneca
NCT06494540 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

30 sites
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

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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