NCT07510724Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 3 Feb 2026
- Start date
- 23 Dec 2025
- Primary completion date
- 23 Dec 2032
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Diseases
- Lung cancer
- NCT number
- NCT07510724
What you commit to
- Study type: Observational
- Planned participants: 240
- From 23 Dec 2025 to the primary completion date, 23 Dec 2032
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- The patient is under 18 years of age at the time of providing signed informed consent.
Other
- The patient has not provided signed informed consent.
- The patient is unable to fully comprehend the implications of study participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Not yet recruiting |
| Krankenhaus Nordwest Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.