Tracks lung cancer patients receiving tislelizumab treatment in everyday practice
Collects real-world data on tislelizumab treatment in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab
Key facts
- Where
- Sankt Pölten, AustriaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer (non-small cell or small cell) whose doctor has already decided on treatment with Tislelizumab. It collects real-world data.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Either resectable non-small cell lung cancer, stage II-IIIA, with high risk of recurrence, planned for surgery with Tislelizumab before and after. Or locally advanced or metastatic non-small cell lung cancer. Or extensive-stage small cell lung cancer.
- Earlier treatment
- For advanced non-small cell lung cancer (squamous, or non-squamous with PD-L1 on at least 50% of tumor cells): no earlier palliative treatment. For extensive-stage small cell lung cancer: no earlier palliative treatment. Other non-small cell lung cancer: earlier platinum-based therapy, plus targeted therapy if EGFR or ALK mutation. Patients who already had 1-2 cycles can still join.
- Biomarker or test result
- Non-squamous non-small cell lung cancer, first treatment: PD-L1 on at least 50% of tumor cells, and no EGFR or ALK mutation.
Main reasons for not taking part
- No signed informed consent
- Under 18 years of age
- Cannot fully understand what taking part means
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
Source: NCT07510724, who can take part
Where in Austria
- Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für GesundheitswissenschaftenSankt Pölten, AustriaContact: Raoul De Jonge, Dr.Not yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Trial code
- NCT07510724
- Record updated
- 3 April 2026
- Original 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.Read full original descriptionShow less
Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab - the ReWoLuTe Study
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.
Inclusion: Patient has a histologically confirmed resectable Non-small cell lung cancer in stage II-IIIA with high risk of recurrence according to the 8th edition of the following AJCC staging criteria and is eligible for an R0 resection with curative intent and treatment with Tislelizumab in neoadjuvant and adjuvant setting:; 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; OR; Patient has a histologically confirmed locally advanced or metastatic lung carcinoma of one of the following subtypes and is eligible for treatment with Tislelizumab in an approved indication:; NSCLC, squamous type, and the patient is not a candidate for surgical resection or platinum-based chemoradiation and did not receive prior treatment in palliative setting,; NSCLC, non-squamous type with PD-L1 expression on ≥50% of tumor cells and without EGFR- or ALK-positive mutations, and patient is not candidate for surgical resection or platinum-based chemoradiation and did not receive prior treatment in palliative setting,; NSCLC, squamous or non-squamous type, and the patient already received prior platinum-based therapy and, if with EGFR- or ALK-positive mutations, also has received targeted therapies,; SCLC, extensive-stage, and the patient has not received prior treatment in palliative setting; A decision for treatment with an authorized Tislelizumab-based regimen has been made by the treating physician before enrolling into ReWoLuTe study; NOTE:; Patients who have already received 1-2 cycles of therapy are still eligible for enrollment into the NIS. Patients who intended to be treated in the curative setting and had to switch before the start of an adjuvant treatment to the palliative setting or BSC (e.g. due to progress or other reasons), will not be excluded from study.
Exclusion: The patient is under 18 years of age at the time of providing signed informed consent; The patient has not provided signed informed consent; The patient is unable to fully comprehend the implications of study participation.