Status:
RECRUITING
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Stage IV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 standar...
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 inter...
Eligibility Criteria
Inclusion
- 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. Neurosurgical diagnostic resection of one single CNS metastasis or laparoscopic resection of one adrenal metastasis before trial inclusion is allowed.
- 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
- 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 another trial if either: interventional trial that aims to improve survival, not permitted by other trial, would result in too much patient burden
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06114108
Start Date
December 21 2023
End Date
November 1 2027
Last Update
February 21 2025
Active Locations (7)
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1
Kantonspital Aarau
Aarau, Switzerland, 5001
2
IOSI Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland, 6500
3
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
4
Hôpital Fribourgeois - Hôpital Cantonal
Fribourg, Switzerland