Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab - the ReWoLuTe Study

Real-world study of Tislelizumab for lung cancer patients

NCT: NCT07510724 · Status: RECRUITING · Phase: N/A · Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Started: 2025-12-23 · Est. Completion: 2033-01-23

Plain English Summary

Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab is a Not Applicable clinical trial sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest studying Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis). This study observes how Tislelizumab, an immune therapy, is used in routine clinical practice for lung cancer. It is for patients with specific types of lung cancer, including Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC). Participation involves receiving Tislelizumab as part of your regular medical care, with data collected on your treatment and outcomes. There are no alternative treatments offered within this study; it observes standard care. The trial aims to enroll 240 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with certain types of Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) who are recommended to receive Tislelizumab by their doctor. This includes patients with high-risk resectable NSCLC, or advanced/metastatic NSCLC or SCLC that meets specific criteria. Patients must be 18 years or older and able to understand the study. Patients who have not provided informed consent or are unable to comprehend study implications cannot join. This trial is studying Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Overall survival means how long patients live from when they start Tislelizumab treatment, offering a key measure of how well the treatment helps patients live longer. The specific primary outcome measures are: Overall survival (OS) (From first Tislelizumab administration up to a maximum of 84 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it will provide valuable information on how Tislelizumab works for lung cancer patients in real-world settings, helping to fill gaps in understanding its effectiveness and s This research targets Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis), where improved treatment options are needed.

Investor Insight

This observational study on Tislelizumab in lung cancer could signal market interest in immune-oncology treatments for this disease, potentially impacting the competitive landscape for similar therapi

Is This Trial Right for Me?

Ask your doctor if Tislelizumab is the right treatment for your specific type and stage of lung cancer. Understand that this is an observational study, meaning your treatment will be based on your doctor's decision and standard care, not experimental. Your medical information and treatment outcomes will be collected and analyzed to understand how Tislelizumab is used in practice. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07510724?

NCT07510724 is a Not Applicable OBSERVATIONAL study titled "Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab." It is currently recruiting and is sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest. The trial targets enrollment of 240 participants.

What conditions does NCT07510724 study?

This trial investigates treatments for Small Cell Lung Cancer (SCLC), Non-Small Cell Lung Cancer (NSCLC), Lung Cancer (Diagnosis). The primary condition under study is Small Cell Lung Cancer (SCLC).

What does Not Applicable mean for NCT07510724?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07510724?

This trial is currently "Recruiting." It started on 2025-12-23. The estimated completion date is 2033-01-23.

Who is sponsoring NCT07510724?

NCT07510724 is sponsored by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07510724?

The trial aims to enroll 240 participants. The trial is currently recruiting and accepting new participants.

How is NCT07510724 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07510724?

The primary outcome measures are: Overall survival (OS) (From first Tislelizumab administration up to a maximum of 84 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07510724 being conducted?

This trial is being conducted at 2 sites, including Sankt Pölten, Lower Austria; Frankfurt am Main, Hesse (Austria, Germany).

Where can I find official information about NCT07510724?

The official record for NCT07510724 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07510724. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07510724 testing in simple terms?

This study observes how Tislelizumab, an immune therapy, is used in routine clinical practice for lung cancer. It is for patients with specific types of lung cancer, including Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC).

Why is this trial significant?

This trial matters because it will provide valuable information on how Tislelizumab works for lung cancer patients in real-world settings, helping to fill gaps in understanding its effectiveness and s

What are the potential risks of participating in NCT07510724?

As this is an observational study, the risks are primarily those associated with Tislelizumab treatment itself, which can include immune-related side effects affecting various organs. Potential side effects may involve fatigue, nausea, rash, and inflammation in organs like the lungs, liver, or intestines. It's important to discuss all potential risks and side effects with your healthcare provider before starting treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07510724?

Ask your doctor if Tislelizumab is the right treatment for your specific type and stage of lung cancer. Understand that this is an observational study, meaning your treatment will be based on your doctor's decision and standard care, not experimental. Your medical information and treatment outcomes will be collected and analyzed to understand how Tislelizumab is used in practice. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07510724 signal from an investment perspective?

This observational study on Tislelizumab in lung cancer could signal market interest in immune-oncology treatments for this disease, potentially impacting the competitive landscape for similar therapi This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving Tislelizumab as part of your regular medical care, with data collected on your treatment and outcomes. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.