Small Cell Lung Cancer (SCLC)IKF-ReWoLuTeNCT07510724
Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab
An observational study of Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis)
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Dec 2025to 23 Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
Sankt Pölten, Lower Austria, 3100
Raoul De Jonge, Dr., +43 2742 9004 12142, raoul.dejonge@stpoelten.lknoe.at
Germany1 site, 1 recruiting
- Recruiting
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488
Akin Atmaca, PD Dr. med., atmaca.akin@khnw.de
Wajdie Tameizi, Tameizi.Wajdie@khnw.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis)
- 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)
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.
Measured: From first Tislelizumab administration up to a maximum of 84 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrolment up to a maximum of 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start23 Dec 2025
- Primary completion23 Dec 2032 (estimated)
- Study completion23 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- Raoul De Jonge, Dr., Principal investigator, Universitätsklinikum St. Pölten - Lilienfeld, ÖsterreichAkin Atmaca, PD Dr. med., Principal investigator, Krankenhaus Nordwest, Frankfurt, Deutschland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510724
- Sponsor's protocol ID
- IKF-ReWoLuTe
- Other IDs
- NIS8049, IKF091
- Acronym
- IKF-ReWoLuTe
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab - the ReWoLuTe Study
- ClinicalTrials.gov ID
- NCT07510724
- Acronym / sponsor ID
- IKF-ReWoLuTe / IKF-ReWoLuTe
- Conditions
- Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis)
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- BeOne Medicines
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 23 Dec 2032 (estimated)
- Study completion
- 23 Jan 2033 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
- 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:
- A decision for treatment with an authorized Tislelizumab-based regimen has been made by the treating physician before enrolling into ReWoLuTe study.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: From first Tislelizumab administration up to a maximum of 84 months
Overall survival (OS) is used as measurement to further characterize the effectiveness of tislelizumab therapy in real-world lung cancer patients.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raoul De Jonge, Dr. principal investigator
Universitätsklinikum St. Pölten - Lilienfeld, Österreich
Akin Atmaca, PD Dr. med. principal investigator
Krankenhaus Nordwest, Frankfurt, Deutschland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akin Atmaca, PD Dr. med. (+49 (0)69 7601 3297, atmaca.akin@khnw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From first Tislelizumab administration up to a maximum of 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.