NCT06494540 NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
| NCT ID | NCT06494540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Non-squamous Metastatic Non-Small-Cell Lung Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-06-28 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06494540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Non-squamous Metastatic Non-Small-Cell Lung Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494540 currently recruiting?
Yes, NCT06494540 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06494540 trial being conducted?
This trial is being conducted at Bad Homburg, Germany, Berlin, Germany, Bremen, Germany, Celle, Germany and 11 additional locations.
Who is sponsoring the NCT06494540 clinical trial?
NCT06494540 is sponsored by AstraZeneca. The trial plans to enroll 600 participants.