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Phase III randomized controlled trial comparing maintenance systemic therapy alone with systemic therapy plus local ablative treatment for patients with advanced stage IV non-small cell lung cancer

Coordinating Investigator

  • Isabelle Schmitt-Opitz

    Leitende Ärztin

Most lung cancer patients receive a diagnosis only when the disease has reached an advanced stage, characterized by metastasis beyond the lungs. At this point, systemic therapy becomes the standard treatment approach. This study endeavors to investigate whether, following a positive response to systemic therapy, treating the primary tumor and metastases with surgery and/or radiation - collectively referred to as local ablative therapy (LAT) - can offer additional benefits for individuals with advanced polymetastatic non-small cell lung cancer (NSCLC) at stage IV.

The primary objective is to assess whether incorporating LAT, subsequent to successful systemic therapy, may prolong the progression-free survival (PFS) and  time. Such an intervention has the potential to bring about a fundamental shift in the current treatment standards for stage IV NSCLC patients, who currently do not routinely undergo surgery and/or radiotherapy following initial systemic anti-cancer treatment.

Acknowledging that the effectiveness of any therapy extends beyond medical outcomes, we recognize the pivotal role of its impact on the quality of life from the patient's standpoint. Factors such as medication side effects, pain, fatigue, nausea, and prolonged hospital stays can significantly influence the perceived positive effects of a therapy. Therefore, an integral aspect of this study involves assessing the quality of life using patient-reported outcome measures (PROMs).

The study aims to enroll a total of 128 participants, randomly assigning them to either the intervention group (LAT) or the control group (systemic therapy alone). In addition to the LAT intervention, participants will be required to visit the hospital approximately six times for study-related assessments. Anticipated to span approximately two years for each participant, this study aspires to shed light on the potential benefits of LAT, ultimately contributing valuable insights that may shape future treatment protocols for stage IV NSCLC patients.

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