Actively Recruiting
Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab - the ReWoLuTe Study
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-04-03
240
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to collect real-world data on the use of Tislelizumab-based therapies in patients with lung cancer, including resectable non-small cell lung cancer (NSCLC) in perioperative settings, locally advanced or metastatic NSCLC, and extensive-stage small cell lung cancer (SCLC). The study evaluates overall survival, treatment patterns, safety, and quality of life among patients receiving Tislelizumab in routine clinical practice across Germany and Austria. It builds on prior clinical evidence to understand how the drug performs in a broader, more diverse population. The study is observational and includes approximately 240 adult patients treated with Tislelizumab according to approved indications. Patients receive Tislelizumab in various settings such as neoadjuvant, adjuvant, or palliative treatment as determined by their physicians. Data collection follows routine care without altering treatment, with assessments during therapy and long-term follow-up lasting up to 84 months (7 years). Optional archival tissue samples may be collected for additional research. Participants will have their overall survival recorded from the start of Tislelizumab treatment. Other measurements include progression-free survival, disease-free survival, event-free survival, treatment duration, treatment interruptions, and quality of life changes assessed by standardized questionnaires. Safety data, including immune-related adverse events, will be monitored and reported regularly. The study runs until 2033, with interim analyses planned as enrollment and follow-up milestones are reached.
CONDITIONS
Brief Title
Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed resectable non-small cell lung cancer (NSCLC) stage II-IIIA with high risk of recurrence and eligible for curative surgery and Tislelizumab treatment in perioperative setting
- Patients with locally advanced or metastatic NSCLC eligible for Tislelizumab treatment including:
- Squamous NSCLC not suitable for surgery or platinum chemoradiation, no prior palliative treatment
- Non-squamous NSCLC with PD-L1 expression ≥50%, no EGFR or ALK mutations, not suitable for surgery or platinum chemoradiation, no prior palliative treatment
- Squamous or non-squamous NSCLC with prior platinum-based therapy and, if applicable, prior targeted therapies for EGFR or ALK mutations
- Patients with extensive-stage small cell lung cancer (SCLC) without prior palliative treatment
- A treatment decision with an authorized Tislelizumab regimen made by the treating physician before study enrollment
- Patients who already received 1-2 cycles of therapy are eligible
You will not qualify if you...
- No signed informed consent provided
- Under 18 years of age at consent
- Unable to fully understand the implications of study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 84 months (7 years)
Participants who receive Tislelizumab treatment as part of their routine clinical care are observed to collect real-world data on treatment patterns, safety, and health-related quality of life.
Regular assessments during treatment according to routine clinical practice
Duration - Up to 84 months (7 years)
Participants are followed for long-term outcomes including overall survival and adverse event profiles after treatment ends.
Follow-up visits according to routine clinical practice
Trial Site Locations
Total: 2 locations
1
Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
Sankt Pölten, Lower Austria, Austria, 3100
Not Yet Recruiting
2
Krankenhaus Nordwest
Frankfurt am Main, Hesse, Germany, 60488
Actively Recruiting
Research Team
A
Akin Atmaca, PD Dr. med.
B
Bianca Zaepf
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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