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Lung cancer drug tislelizumab under Real-World microscope

NCT ID NCT07510724

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Krankenhaus Nordwest

    RECRUITING

    Frankfurt am Main, Hesse, 60488, Germany

  • Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften

    NOT_YET_RECRUITING

    Sankt Pölten, Lower Austria, 3100, Austria

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