NCT06114108

Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and/or radiation.

Detailed description

In this study, the aim is to find out whether, after a good response to standard therapy, it is better if the main tumor and metastases are additionally removed by surgery and/or radiation. This intervention is referred to as local ablative therapy (LAT). There is evidence to suggest that this additional intervention may prolong the average time to possible cancer recurrence (PFS: Progression-free survival) or lead to longer survival on average. Therefore, the question is to know if these treatments prolong life, and if so, by how much and with what implications. Currently, patients who respond to initial standard therapy are not routinely offered LAT. If the results of this study are positive, it will lead to a fundamental change in the current standard of practice. The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patient's quality of life. Medication side effects, pain, fatigue, nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patient's viewpoint, even if it appears favorable from a medical standpoint. Therefore, the assessment of quality of life through patient-reported outcome measures (PROMs) is a central aspect of this study. This study will enroll 128 patients from different Swiss hospitals, randomly assigning them to either the intervention group (LAT) or a control group (standard therapy). The study is expected to span approximately two years for each patient.

Conditions

• Non-small Cell Lung Cancer (NSCLC)
• Stage IV

Interventions

Type	Name	Description
OTHER	Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)	The choice of LAT intervention for the primary tumor and all metastases (surgery or SBRT) and the sequence of the treatment (primary tumor vs metastases) will be decided at the local MDT according to the medical need and patient counseling during interdisciplinary clinic visits.
OTHER	Surgery	Surgery
RADIATION	Radiotherapy	Radiotherapy

Timeline

• Start date: 2023-12-21
• Primary completion: 2027-11-01
• Completion: 2028-03-01
• First posted: 2023-11-02
• Last updated: 2026-04-02

Locations

7 sites across 1 country: Switzerland