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
Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population — Time from patient's index date until death by any cause, up to 24 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in the total study population. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS — Time from patient's index date until death by any cause, up to 24 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in KRAS. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11 — Time from patient's index date until death by any cause, up to 24 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in STK11. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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