ATOM_local Ablative Therapy

Inclusion criteria

• Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
• Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
• Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
• Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
• The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Age ≥ 18 years
• Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
• Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
• Adequate organ function as defined by the following criteria:

• Serum alanine transaminase ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to liver metastases
• Total bilirubin ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets count ≥ 100 x 109/L
• Creatinine clearance > 45ml/min
• Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria

• Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
• Prior radiotherapy is not allowed except brain irradiation
• Leptomeningeal carcinomatosis
• Lymphangitis carcinomatosis of lung
• Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
• Uncontrolled active infection or medical condition (e.g. uncontrolled hypertension, unstable angina, congestive heart failure [≥ NYHA Class II], uncontrolled arrhythmia, myocardial infarction or cerebrovascular accident within the past 6 month)
• Pre-existing interstitial lung disease
• Woman of child-bearing potential or male patient is unwilling to use adequate birth control method prior to the study entry, for the duration of study participation and for at least 2 months after the EGFR TKI treatment has ended.
• Pregnant and Lactating female patient
• Non-compliance to the study procedure