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NCT Number: NCT05538806

TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.

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Key information

Conditions

Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lungenklinik Gauting, Gauting, Bavaria, 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

  • ≥ 18 years of age
  • Histologically confirmed pleural mesothelioma without any option of curative resection
  • Planned treatment with NovoTTF-200T System according to IFU and medical guidelines
  • Life expectancy more than 3 months at day of enrollment
  • Signed informed consent for use and processing of data

Exclusion criteria

  • Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment

Treatment and study plan

TTFields

Device

all patients will receive routine clinical care and TTFields

Primary outcomes

  1. Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.

    Time frame: 54 Months

Secondary outcomes

  1. Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.

    Time frame: 3 years + 18 months follow up

  2. Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.

    Time frame: QoL will be assessed at baseline, 3 and 6 months.

Study contacts

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

Giovanni Ceresoli

CONTACT

[email protected]

+392 9626717

Sponsors and collaborators

Lead sponsor

NovoCure Ltd.

Industry

Registry information

Official study title

TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study

Acronym: TIGER Meso

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 14, 2022
Registry last updated
Aug 22, 2025

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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