NCT07510724

Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab

Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab - the ReWoLuTe Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The study includes adult 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. Approximately 240 patients will be enrolled across about 38 sites. ReWoLuTe builds on strong clinical evidence from phase III RATIONALE studies and seeks to understand the drug's performance in a broader, more heterogeneous population typically underrepresented in clinical trials. Data collection follows routine clinical practice, including regular assessments during treatment and long-term follow-up for up to five years. Endpoints include overall survival (primary) and multiple secondary measures such as PFS, DFS, EFS, treatment duration, HRQoL deterioration, and adverse event profiles. Safety data-including immune-mediated events-will be systematically captured and reported according to regulatory requirements. The study is scheduled to run up to 2033, with interim analyses planned after enrollment and follow-up milestones. Optional archival tissue collection will support accompanying translational research.

Conditions

• Small Cell Lung Cancer (SCLC)
• Non-Small Cell Lung Cancer (NSCLC)
• Lung Cancer (Diagnosis)

Timeline

• Start date: 2025-12-23
• Primary completion: 2032-12-23
• Completion: 2033-01-23
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

2 sites across 2 countries: Austria, Germany