Status:
RECRUITING
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
Lead Sponsor:
AstraZeneca
Conditions:
Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18-120 years
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 ...
Eligibility Criteria
Inclusion
- 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
- Current participation in interventional clinical trials
- Contraindications according to current SmPCs
- Any active tumor other than metastatic NSCLC
Key Trial Info
Start Date :
June 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06494540
Start Date
June 28 2024
End Date
June 30 2028
Last Update
November 17 2025
Active Locations (20)
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1
Research Site
Bad Homburg, Germany
2
Research Site
Berlin, Germany
3
Research Site
Celle, Germany
4
Research Site
Chemnitz, Germany