NCT07510724|Recruiting
Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab
IKF-ReWoLuTe
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IKF-ReWoLuTe
Sponsor study identifier
Secondary identifiers
OTHER · Paul-Ehrlich Institut (PEI)
OTHER · IKF trial ID
observational
240
2 countries
2
Study Start
December 23, 2025
Actual (reported)Primary Completion
December 23, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 23, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 23, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2025
Actual (reported)February 3, 2026
Actual (reported)April 3, 2026
Actual (reported)December 23, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 23, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall survival (OS)
Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.
From first Tislelizumab administration up to a maximum of 84 months
Duration of treatment (DoT)
From enrolment up to a maximum of 84 months.
Progression-free survival (PFS)
From first Tislelizumab administration up to a maximum of 84 months
The study includes adult lung cancer patients with resectable NSCLC (perioperative setting), locally advanced or metastatic NSCLC (1st/2nd line), or extensive-stage SCLC (1st line) who are receiving Tislelizumab according to its approved indications.
The ReWoLuTe study enrolls patients in Germany and Austria of both sexes and ages over 18 years. All patients are diagnosed with resectable non-small cell lung carcinoma (NSCLC) in the perioperative curative setting OR locally advanced or metastatic NSCLC in the 1st or 2nd line therapy setting OR small cell lung carcinoma (SCLC) in the 1st line therapy setting, with no local curative therapy available AND treated with a tislelizumab-based therapy according to label.
Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
Sankt Pölten, Lower Austria, 3100, Austria
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488, Germany
tumor tissue (formalin-fixed paraffin embedded tissue)
Raoul De Jonge, Dr.
Universitätsklinikum St. Pölten - Lilienfeld, Österreich
Akin Atmaca, PD Dr. med.
Krankenhaus Nordwest, Frankfurt, Deutschland
First Submitted
February 3, 2026
First Posted
April 3, 2026
Study Start
December 23, 2025
Actual (reported)Primary Completion
December 23, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Disease-free survival (DFS)
From date of resection up to a maximum of 84 months
Event-Free Survival (EFS)
From first Tislelizumab administration up to a maximum of 84 months
Tislelizumab treatment dose in lung cancer patients
From enrolment up to a maximum of 84 months
Contact the study team to confirm eligibility.
Study Completion
January 23, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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