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.
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.
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.
The ReWoLuTe study enrolls patients in Germany and Austria of both sexes and ages over 18 years. All patients are diagnosed with resectable non-small cell lung carcinoma (NSCLC) in the perioperative curative setting OR locally advanced or metastatic NSCLC in the 1st or 2nd line therapy setting OR small cell lung carcinoma (SCLC) in the 1st line therapy setting, with no local curative therapy available AND treated with a tislelizumab-based therapy according to label.
Cohort
Prospective
Not listed
Overall survival (OS)
Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.
Duration of treatment (DoT)
Duration of treatment (DoT), defined as time from date of first Tislelizumab administration to the date of treatment discontinuation due to any cause.
Progression-free survival (PFS)
Progression-free survival (PFS), defined as time from date of first Tislelizumab administration to the date of progression according to the attending physician's judgement or death due to any cause, whichever occurs first.
Disease-free survival (DFS)
Disease-free survival (DFS), defined as the time from the date of resection until the first documented disease-related event or death from any cause, whichever occurs first. Disease-related events include local recurrence, regional recurrence, distant metastasis, or the occurrence of a second primary malignancy.
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from date of first Tislelizumab administration until the occurrence of any of the following events: disease progression prior to surgery that precludes curative resection, failure to undergo curative-intent surgery for any disease-related reason, postoperative disease recurrence (local, regional, or distant), or death from any cause.
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
BeOne Medicines
Collaborator
