An observational study in Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC) and Lung Cancer (Diagnosis), sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Observational
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.
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.
The study includes adult patients with resectable NSCLC (perioperative setting), locally advanced or metastatic NSCLC (1st/2nd line), or extensive-stage SCLC (1st line) who are receiving Tislelizumab according to its approved indications. Approximately 240 patients will be enrolled across about 38 sites.
ReWoLuTe builds on strong clinical evidence from phase III RATIONALE studies and seeks to understand the drug's performance in a broader, more heterogeneous population typically underrepresented in clinical trials. Data collection follows routine clinical practice, including regular assessments during treatment and long-term follow-up for up to five years.
Endpoints include overall survival (primary) and multiple secondary measures such as PFS, DFS, EFS, treatment duration, HRQoL deterioration, and adverse event profiles. Safety data-including immune-mediated events-will be systematically captured and reported according to regulatory requirements.
The study is scheduled to run up to 2033, with interim analyses planned after enrollment and follow-up milestones. Optional archival tissue collection will support accompanying translational research.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 240 is above the median of 150 across 121 observational studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
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:
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 study includes adult lung cancer patients with resectable NSCLC (perioperative setting), locally advanced or metastatic NSCLC (1st/2nd line), or extensive-stage SCLC (1st line) who are receiving Tislelizumab according to its approved indications.
Overall survival (OS)
Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.
Time frame: From first Tislelizumab administration up to a maximum of 84 months
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.
Time frame: From enrolment up to a maximum of 84 months.
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.
Time frame: From first Tislelizumab administration up to a maximum of 84 months
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.
Time frame: From date of resection up to a maximum of 84 months
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.
Time frame: From first Tislelizumab administration up to a maximum of 84 months
Tislelizumab treatment dose in lung cancer patients
Total treatment dose across lines of therapy in patients treated with Tislelizumab.
Time frame: From enrolment up to a maximum of 84 months
Tislelizumab treatment frequency in lung cancer patients
Treatment frequency assessed as numbers of cycles across lines of therapy in patients treated with Tislelizumab.
Time frame: From enrolment up to a maximum of 84 months
Tislelizumab duration of treatment delays in lung cancer patients
Duration of of treatment delays across lines of therapy in patients treated with Tislelizumab.
Time frame: From enrolment up to a maximum of 84 months
Tislelizumab temporary treatment interruptions in lung cancer patients
Treatment interruptions across lines of therapy in patients treated with Tislelizumab
Time frame: From enrolment up to a maximum of 84 months
Time to Health-Related Quality of Life (HR-QoL) Deterioration as assessed by EORTC QLQ-C30
Time to Health-Related Quality of Life (HR-QoL) Deterioration (TTD), measured from start of Tislelizumab treatment to the first ≥10 points decrease of HR-QoL score compared to baseline HR-QoL score with HR-QoL scores derived from EORTC QLQ-C30
Time frame: From start of Tislelizumab treatment up to a maximum of 84 months
Time to Health-Related Quality of Life (HR-QoL) Deterioration as assessed by EORTC QLQ-LC13
Time to Health-Related Quality of Life (HR-QoL) Deterioration (TTD), measured from start of Tislelizumab treatment to the first ≥10 points decrease of HR-QoL score compared to baseline HR-QoL score with HR-QoL scores derived from EORTC QLQ-LC13
Time frame: From start of Tislelizumab treatment up to a maximum of 84 months
Adverse event profiles
AE frequency, listed with severity, drug-relation, and management of the following groups of AEs: Selected AEs (immune-mediated pneumonitis, colitis, hepatitis, nephritis/renal dysfunction, endocrinopathies, and rash), other immune-mediated AEs (imAEs), other treatment-related AEs, fatal AEs.
Time frame: From enrolment up to a maximum of 84 months
Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available.
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest