Tislelizumab treatment for people with lung cancer in routine care

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

We will see how tislelizumab is used and how patients with resectable, locally advanced, or extensive-stage lung cancer do when treated in everyday clinical care in Germany and Austria.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (Academic / other)
• Drugs / interventions: Tislelizumab
• Locations: 2 sites (Sankt Pölten, Lower Austria and 1 other locations)
• Trial ID: NCT07510724 on ClinicalTrials.gov

What this trial studies

ReWoLuTe is a prospective, multicenter observational cohort collecting real-world data on adults treated with tislelizumab across approximately 38 sites in Germany and Austria, enrolling about 240 patients. Data are collected during routine clinical visits and include treatment patterns, safety events (including immune-mediated adverse events), and patient-reported health-related quality of life, with planned long-term follow-up for up to five years. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, disease-free survival, event-free survival, treatment duration, HRQoL deterioration, and adverse event profiles. The study is designed to complement phase III RATIONALE trial evidence by describing effectiveness and safety in a broader, more heterogeneous population seen in routine practice.

Who should consider this trial

Good fit: Adults in Germany or Austria with resectable NSCLC in the perioperative setting, locally advanced or metastatic NSCLC (1st/2nd line), or extensive-stage SCLC (1st line) who are receiving tislelizumab per approved indications are eligible.

Not a fit: Patients who are not receiving tislelizumab, who have other cancer types or stages outside the eligibility criteria, or who are treated outside participating centers are unlikely to gain benefit from joining this cohort.

Why it matters

Potential benefit: If successful, this work could give doctors better real-world information on the effectiveness and safety of tislelizumab to guide treatment choices for lung cancer patients.

How similar studies have performed: Phase III RATIONALE trials have shown positive results for tislelizumab in related lung cancer settings, and this observational study examines how those results translate into routine clinical practice.

Eligibility criteria

Inclusion criteria:

* 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:

  1. Tumor size \>4cm; or tumors of any size with either N1 or N2 status
  2. Tumors invading thoracic structures (directly into the visceral pleura, parietal pleura, chest wall, main bronchus, phrenic nerve, mediastinal pleura, parietal pericardium)
  3. 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)
  4. 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:
  5. 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,
  6. 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,
  7. 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,
  8. 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 criteria:

* The patient has not provided signed informed consent.
* The patient is under 18 years of age at the time of providing signed informed consent.
* The patient is unable to fully comprehend the implications of study participation.

Where this trial is running

Sankt Pölten, Lower Austria and 1 other locations

• Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften — Sankt Pölten, Lower Austria, Austria (Not_yet_recruiting)
• Krankenhaus Nordwest — Frankfurt am Main, Hesse, Germany (Recruiting)

Study contacts

• Principal investigator: Raoul De Jonge, Dr. — Universitätsklinikum St. Pölten - Lilienfeld, Österreich
• Study coordinator: Akin Atmaca, PD Dr. med.

Conditions Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Lung Cancer; Tislelizumab-based therapy; real-world data on tislelizumab treated patients; resectable NSCLC; locally advanced or metastatic NSCLC; extensive-stage SCLC