Lung cancer drug tislelizumab under Real-World microscope
NCT ID NCT07510724
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is watching how lung cancer patients do when they get the drug tislelizumab in normal doctor visits, not in a strict research setting. About 240 people with small cell or non-small cell lung cancer will take part. The goal is to see how long they live, how the drug affects their quality of life, and what side effects happen.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Krankenhaus Nordwest
RECRUITINGFrankfurt am Main, Hesse, 60488, Germany
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Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
NOT_YET_RECRUITINGSankt Pölten, Lower Austria, 3100, Austria
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