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

Official title

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

Overview

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.

Detailed 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.

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.

Primary outcome measures

• Overall survival (OS) [Time frame: From first Tislelizumab administration up to a maximum of 84 months]

Secondary outcome measures (11)

• Duration of treatment (DoT) [Time frame: From enrolment up to a maximum of 84 months.]
• Progression-free survival (PFS) [Time frame: From first Tislelizumab administration up to a maximum of 84 months]
• Disease-free survival (DFS) [Time frame: From date of resection up to a maximum of 84 months]
• Event-Free Survival (EFS) [Time frame: From first Tislelizumab administration up to a maximum of 84 months]
• Tislelizumab treatment dose in lung cancer patients [Time frame: From enrolment up to a maximum of 84 months]
• Tislelizumab treatment frequency in lung cancer patients [Time frame: From enrolment up to a maximum of 84 months]
• Tislelizumab duration of treatment delays in lung cancer patients [Time frame: From enrolment up to a maximum of 84 months]
• Tislelizumab temporary treatment interruptions in lung cancer patients [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 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 frame: From start of Tislelizumab treatment up to a maximum of 84 months]
• Adverse event profiles [Time frame: From enrolment up to a maximum of 84 months]

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:

• 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Austria · 1 center

• Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesun — Sankt Pölten

Germany · 1 center

• Krankenhaus Nordwest — Frankfurt am Main

Identifiers

NCT: NCT07510724 · IKF-ReWoLuTe · NIS8049 · IKF091

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗