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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer (NSCLC); Small Cell Lung Cancer (SCLC); Lung Cancer (Diagnosis)

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Akin Atmaca, PD Dr. med.; Phone Number: +49 (0)69 7601 3297; Email: atmaca.akin@khnw.de
• Study Contact Backup: Name: Bianca Zaepf; Phone Number: or -78 +49 (0)69 5899 787-19; Email: rewolute@ikf-khnw.de

Study Locations

• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Not yet recruiting
      • Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
      • Contact: Raoul De Jonge, Dr.; Phone Number: +43 2742 9004 12142; Email: raoul.dejonge@stpoelten.lknoe.at
• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60488
      • Recruiting
      • Krankenhaus Nordwest
      • Contact: Akin Atmaca, PD Dr. med.; Email: atmaca.akin@khnw.de
      • Contact: Wajdie Tameizi; Email: Tameizi.Wajdie@khnw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung Cancer patients receiving Tislelizumab according to label; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.	From first Tislelizumab administration up to a maximum of 84 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	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	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	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.	From enrolment up to a maximum of 84 months

Collaborators and Investigators

• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Collaborators: BeOne Medicines
• Investigators: Principal Investigator: Raoul De Jonge, Dr., Universitätsklinikum St. Pölten - Lilienfeld, Österreich; Principal Investigator: Akin Atmaca, PD Dr. med., Krankenhaus Nordwest, Frankfurt, Deutschland

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): December 23, 2032
• Study Completion (Estimated): January 23, 2033

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; Tislelizumab-based therapy; real-world data on tislelizumab treated patients; resectable NSCLC (perioperative setting); locally advanced or metastatic NSCLC (1st/2nd line); extensive-stage SCLC (1st line)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: IKF-ReWoLuTe; NIS8049 (Other Identifier: Paul-Ehrlich Institut (PEI)); IKF091 (Other Identifier: IKF trial ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No