Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
Recruiting · NCT06114108 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
RadiotherapySurgerySystemic therapy alone or in combination with LAT (surgery and/or radiotherapy)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients fulfilling all of the following inclusion criteria at screening may be enrolled in the trial.
- The inclusion criteria are irrespective from the tumor burden at the time of primary diagnosis before initiation of first line systemic therapy. Treatment of brain metastases upfront or after an induction phase of standard systemic therapy is done according to the standard practice of the treating center.
- Adults (18 years or older)
- Tissue confirmed, pre-treatment clinical stage IV NSCLC
- ECOG performance status ≤ 1
- Patients responding after 3 cycles (4th bridging cycle up until randomization is allowed) or 3 months of first line SoC systemic therapy with PR or SD in restaging imaging, and presenting with (induced) oligometastatic or oligopersistent NSCLC defined as a maximum of 5 residual extracranial, distant metastases
- Patients may have up to 5 cranial metastases in addition to the oligoresidual extracranial metastases as long as they are amenable for radiotherapy or surgery.
- The primary tumor and all oligopersistent metastases must be amenable for radical LAT (surgery or radiotherapy)
- Patients of reproductive age agree to use double contraception during the study
- Patient is able to understand trial procedures and is able/willing to adhere to trial procedures as confirmed by signature
Exclusion criteria
- The presence of any one of the following exclusion criteria at screening will lead to exclusion of the participant:
- Serious concomitant disorder that would compromise patient safety during LAT
- Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2
- Metastatic locations such as malignant ascites, malignant pleural or malignant pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques, leptomeningeal carcinomatosis
- Women who are pregnant or breast feeding
- Patient is currently involved in a trial that either does not permit participation in other trials or would result in excessive patient burden if another trial were joined. In such cases, the co-investigators' team and the Patient Advisory Board will decide on participation on an individual basis.
Where it is running
7 locations listed.
- Kantonspital Aarau - Aarau, Switzerland
- IOSI Ospedale Regionale di Bellinzona e Valli - Bellinzona, Switzerland
- Kantonsspital Graubuenden - Chur, Switzerland
- Hôpital Fribourgeois - Hôpital Cantonal - Fribourg, Switzerland
- Hôpitaux Universitaires Genève HUG - Geneva, Switzerland
- Luzerner Kantonsspital - Lucerne, Switzerland
- Universitätsspital Zürich - Zurich, Switzerland