Lung Cancer (Diagnosis), Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC)
Conditions
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)
Brief 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. 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.
Interventions
None listed
Sponsors
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
BeOne Medicines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment (DoT) | From enrolment up to a maximum of 84 months. | 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) | From first Tislelizumab administration up to a maximum of 84 months | 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) | From date of resection up to a maximum of 84 months | 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) | From first Tislelizumab administration up to a maximum of 84 months | 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. |
| Tislelizumab treatment dose in lung cancer patients | From enrolment up to a maximum of 84 months | Total treatment dose across lines of therapy in patients treated with Tislelizumab. |
| Tislelizumab treatment frequency in lung cancer patients | From enrolment up to a maximum of 84 months | Treatment frequency assessed as numbers of cycles across lines of therapy in patients treated with Tislelizumab. |
| Tislelizumab duration of treatment delays in lung cancer patients | From enrolment up to a maximum of 84 months | Duration of of treatment delays across lines of therapy in patients treated with Tislelizumab. |
| Tislelizumab temporary treatment interruptions in lung cancer patients | From enrolment up to a maximum of 84 months | Treatment interruptions across lines of therapy in patients treated with Tislelizumab |
| Time to Health-Related Quality of Life (HR-QoL) Deterioration as assessed by 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 (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 to Health-Related Quality of Life (HR-QoL) Deterioration as assessed by EORTC QLQ-LC13 | From start of Tislelizumab treatment up to a maximum of 84 months | 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 |
| Adverse event profiles | From enrolment up to a maximum of 84 months | 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. |
Countries
Austria, Germany
Contacts
CONTACTAkin Atmaca, PD Dr. med.
CONTACTBianca Zaepf
PRINCIPAL_INVESTIGATORRaoul De Jonge, Dr.
Universitätsklinikum St. Pölten - Lilienfeld, Österreich
PRINCIPAL_INVESTIGATORAkin Atmaca, PD Dr. med.
Krankenhaus Nordwest, Frankfurt, Deutschland
Outcome results
None listed