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Table 1 Key Inclusion and Exclusion Criteria

From: Phase II study of multidisciplinary therapy combined with pembrolizumab for patients with synchronous oligometastatic non-small cell lung cancer TRAP OLIGO study (WJOG11118L)

Inclusion criteria

1. Age ≥ 20 years, < 75 years

2. Written informed consent

3. Histologically or cytologically confirmed NSCLC

4. Activating driver mutation negative or unknown: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene 1 (ROS1), BRAF and METa

5. No previous chemotherapy

6. Synchronous oligo-metastatic stage IV disease: maximum of three distant metastasesb

7. Suitable candidate for LAT (radiotherapy and/or surgery) to all site of disease, as determined by a multidisciplinary tumour board

8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

9. No malignant dissemination, pericardial effusion, leptomeningeal metastases, peritoneal dissemination and ascites

10. Adequate hematologic and organ function

Exclusion criteria

1. Presence of any other active cancer

2. Presence of active infections requiring antibiotics

3. History of active autoimmune disease requiring systemic treatment

4. History of interstitial lung disease diagnosed or severe chronic obstructive pulmonary disease (COPD)

  1. aEGFR/ALK/ROS-1/BRAF/MET testing is not mandatory for patients with squamous carcinoma
  2. bBased on a previous study, any metastatic thoracic lymph nodes (N1–N3), including in the supraclavicular fossae, were collectively considered a single metastasis