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Recruiting NCT06494540

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

— Observational Non-squamous Metastatic Non-Small-Cell Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Non-interventional Study (NIS) to Examine the Effectiveness of Tremelimumab + Durvalumab + Platinum Chemotherapy (TDC) in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

Overview

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.

Primary outcome measures

  • Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population [Time frame: Time from patient's index date until death by any cause, up to 24 months]
  • Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS [Time frame: Time from patient's index date until death by any cause, up to 24 months]
  • Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11 [Time frame: Time from patient's index date until death by any cause, up to 24 months]
Secondary outcome measures (10)
  • Real-world overall survival (rwOS) in the total study population [Time frame: 6, 12 and 18 months]
  • Median overall survival (mOS) in the total study population [Time frame: up to 24 months]
  • Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS [Time frame: 6, 12 and 18 months]
  • Median overall survival (mOS) in a subgroup of patients with mutation in KRAS [Time frame: up to 24 months]
  • Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11 [Time frame: 6, 12 and 18 months]
  • Median overall survival (mOS) in a subgroup of patients with mutation in STK11 [Time frame: up to 24 months]
  • Real-world treatment response of TDC, as judged by the treating physician [Time frame: up to 24 months]
  • Duration of response (DoR) [Time frame: up to 24 months]
  • Real-world progression-free survival (rwPFS) [Time frame: up to 24 months]
  • Safety: Collection of Adverse Events (AE) [Time frame: up to 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 29 centers
  • Research Site — Bad Homburg
  • Research Site — Berlin
  • Research Site — Bremen
  • Research Site — Celle
  • Research Site — Chemnitz
  • Research Site — Cologne
  • Research Site — Deggendorf
  • Research Site — Frankfurt
  • … and 21 more centers

Identifiers

NCT: NCT06494540 · D419MR00003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗