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

Last updated: July 11, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06494540
D419MR00003
  • Ages 18-120
  • All Genders

Study 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 Criteria

Inclusion

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 ifconsidered NSCLC-like by the treating physician)

  • Treatment-naïve for metastatic disease

  • No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplasticlymphoma kinase (ALK) alterations

  • Molecular Next Generation Sequencing (NGS) panel as per institutional standard hasbeen 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 treatmentwith 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 localprovisions

Exclusion

Exclusion Criteria:

  • Current participation in interventional clinical trials

  • Contraindications according to current SmPCs

Study Design

Total Participants: 600
Study Start date:
June 28, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Research Site

    Bad Homburg,
    Germany

    Active - Recruiting

  • Research Site

    Berlin,
    Germany

    Active - Recruiting

  • Research Site

    Celle,
    Germany

    Active - Recruiting

  • Research Site

    Chemnitz,
    Germany

    Active - Recruiting

  • Research Site

    Georgsmarienhutte,
    Germany

    Active - Recruiting

  • Research Site

    Gera,
    Germany

    Site Not Available

  • Research Site

    Goslar,
    Germany

    Active - Recruiting

  • Research Site

    Gostar,
    Germany

    Site Not Available

  • Research Site

    Hannover,
    Germany

    Active - Recruiting

  • Research Site

    Herne,
    Germany

    Active - Recruiting

  • Research Site

    Munnerstadt,
    Germany

    Active - Recruiting

  • Research Site

    Neuss,
    Germany

    Active - Recruiting

  • Research Site

    Ravensburg,
    Germany

    Active - Recruiting

  • Research Site

    Treuenbrietzen,
    Germany

    Active - Recruiting

  • Research Site

    Ulm,
    Germany

    Active - Recruiting

  • Research Site

    Wiesbaden,
    Germany

    Active - Recruiting

  • Research Site

    Zwickau,
    Germany

    Active - Recruiting

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