Tislelizumab treatment for people with lung cancer in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ReWoLuTe is a prospective, multicenter observational cohort collecting real-world data on adults treated with tislelizumab across approximately 38 sites in Germany and Austria, enrolling about 240 patients. Data are collected during routine clinical visits and include treatment patterns, safety events (including immune-mediated adverse events), and patient-reported health-related quality of life, with planned long-term follow-up for up to five years. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, disease-free survival, event-free survival, treatment duration, HRQoL deterioration, and adverse event profiles. The study is designed to complement phase III RATIONALE trial evidence by describing effectiveness and safety in a broader, more heterogeneous population seen in routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Krankenhaus Nordwest
  Frankfurt am Main, Hesse, Germany Recruiting
• Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
  Sankt Pölten, Lower Austria, Austria Not yet recruiting

Study contacts

• Principal investigator: Raoul De Jonge, Dr. — Universitätsklinikum St. Pölten - Lilienfeld, Österreich
• Study coordinator: Akin Atmaca, PD Dr. med.
• Email: atmaca.akin@khnw.de
• Phone: +49 (0)69 7601 3297

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.