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

Korábbi kezelés

• Serious concomitant disorder that would compromise patient safety during LAT

Más betegség

• 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

Egyéb

• The presence of any one of the following exclusion criteria at screening will lead to exclusion of the participant:
• Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2
• 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.

• 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