OMEGA, Local Ablative Therapy in Oligometastatic NSCLC (OMEGA)

Inclusion criteria

• ECOG performance status 0-1 at the time of randomization
• Pathologically confirmed NSCLC.
• Staging with whole-body FDG PET scan and brain MRI or CT with IV contrast.
• Between 1 and 3 metastatic lesions, assessable according to RECIST v1.1 and suitable for LAT prior to trial registration.
• Primary tumor controlled (metachronous oligometastasis) or resectable/suitable for ablative radiotherapy.
• Patient is deemed fit to receive at least 3 cycles of platinum-based doublet chemotherapy, cisplatin or carboplatin, according to local guidelines.
• If pulmonary involvement, it must be bilateral with at least 3 lung lesions, or extrapulmonary metastasis must be present
• If brain involvement, up to 2 brain metastases, the largest brain lesion < 3cm in maximum diameter at the time of randomization.

Exclusion criteria

• Any tumor site besides brain metastasis requiring immediate LAT for palliation.
• Patient has received previous LAT for extra-cerebral metastasis
• Patient has received previous systemic treatment for his/her NSCLC malignancy and is experiencing disease progression at the time of randomization (except adjuvant chemotherapy and/or radiotherapy more than 6 months earlier)
• Patient has had palliative radiotherapy to any tumor site prior to registration and/or requires palliative radiotherapy prior to randomization.
• High clinical suspicion of direct invasion of the wall of any major blood vessel or medulla by the primary tumor or metastasis
• Brain metastasis within the brainstem, or leptomeningeal disease.
• Metastasis in sites where normal radiotherapy constraints cannot be met or in a previously irradiated area
• Malignant pleural or pericardial effusion.
• Lung tumors with a single additional nodule in the same lobe, same lung or in the contralateral lung, i.e. T3, T4 or M1a lung cancer, in the absence of extrapulmonary involvement.
• Lung involvement in the form of multiple nonsolid or subsolid nodules, in the absence of extrapulmonary metastasis [18]
• History of prior malignant tumour likely to interfere with the protocol treatment or comparisons (excluding H&N primary, radically treated, no recurrence over the last 5 years, non-melanoma skin cancer, in situ cervical cancer, DCIS or LCIS of the breast
• Any relevant co-morbidities that would significantly reduce life expectancy on their own, such as heart failure, advanced COPD, uncontrolled diabetes, end-stage renal disease etc.
• Women who are pregnant or breast feeding.