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NCT Number: NCT06494540

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

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.

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Key information

Conditions

Non-squamous Metastatic Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bad Homburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Secondary outcomes

  1. Real-world overall survival (rwOS) in the total study population

    Time frame: 6, 12 and 18 months

    rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

  2. Median overall survival (mOS) in the total study population

    Time frame: up to 24 months

    OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

  3. Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS

    Time frame: 6, 12 and 18 months

    rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

  4. Median overall survival (mOS) in a subgroup of patients with mutation in KRAS

    Time frame: up to 24 months

    OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

  5. Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11

    Time frame: 6, 12 and 18 months

    rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

  6. Median overall survival (mOS) in a subgroup of patients with mutation in STK11

    Time frame: up to 24 months

    OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

  7. Real-world treatment response of TDC, as judged by the treating physician

    Time frame: up to 24 months

    Treatment response in terms of overall response rate (ORR), being defined as the proportion of patients with complete response (CR) or partial response (PR) as best overall response, CR or PR, at ≥1 visit during treatment with TDC.

  8. Duration of response (DoR)

    Time frame: up to 24 months

    Duration of response (DoR), being defined as time from documented CR or PR until documentation of progressive disease (PD), or death by any cause will be analyzed with Kaplan-Meier methods. Patients without documentation of PD will be censored with their last date in the database known to be without PD, or the end of study date, whichever occurs first. Patients who received a subsequent line mNSCLC therapy after TDC before disease progression or death will be censored with the start date of this new therapy.

  9. Real-world progression-free survival (rwPFS)

    Time frame: up to 24 months

    rwPFS is defined as time from patient's index date until first date of PD or death by any cause and will be analyzed by Kaplan-Meier methods.

  10. Safety: Collection of Adverse Events (AE)

    Time frame: up to 24 months

    Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: NAUTIC

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 10, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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