About this trial

The ReWoLuTe study (IKF091) is a prospective, multi-center, observational cohort study conducted in Germany and Austria to collect real-world data on the use of Tislelizumab-based therapies in patients with lung cancer. The study aims to evaluate the overall survival, treatment patterns, safety, and health-related quality of life of patients receiving Tislelizumab in everyday clinical practice.

Eligibility criteria

Qualifiers

Tumor size >4cm; or tumors of any size with either N1 or N2 status

Tumors invading thoracic structures (directly into the visceral pleura, parietal pleura, chest wall, main bronchus, phrenic nerve, mediastinal pleura, parietal pericardium)

Tumors >4cm that cause obstructive atelectasis extending to the hilum and involving parts of the lung, the entire lung or a main bronchus, regardless of the distance to the carina, or that invade the visceral pleura (PL1 or PL2)

Tumors with one or more separate nodules in the same lobe as the primary lung carcinoma.

Disqualifiers

The patient has not provided signed informed consent.

The patient is under 18 years of age at the time of providing signed informed consent.

The patient is unable to fully comprehend the implications of study participation.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

240 Participants
are grouped into 1 trial group

Locations

2
Austria
Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften3100, Sankt PöltenLower Austria, Austria
Germany
Krankenhaus Nordwest60488, Frankfurt am MainHesse, Germany

Sponsors and collaborators

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Lead sponsor

BeOne Medicines

Collaborator