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

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.

Eligibility

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. 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 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 another trial if either: interventional trial that aims to improve survival, not permitted by other trial, would result in too much patient burden

Conditions4

Browse More Trials