Inclusion Criteria

Inclusion Criteria summary

1. Provision of written informed consent

2. Patients age 20 years or older

3. Histological or cytological confirmed advanced (stageIV) nonsquamous NSCLC

4. NSCLC treatment naïve(except patients who have pre- and post-operative non-platinum
based adjuvant chemotherapy greater than 6 months prior to enrolment can be
enrolled.)

5. Measurable disease according to RECIST (Version 1.1) criteria

6. World Health Organization (WHO) performance status (PS) of 0 to 1

7. Provision of cancer tissue sample for mutation testing or the result of EGFR mutation
test is negative (single T790M mutation positive patients can also be enrolled)

Exclusion Criteria summary

1. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been
definitively treated with surgery and/or radiation.

2. Known severe hypersensitivity to gefitinib, pemetrexed, cisplatin and carboplatin or
any of the excipients of these products

3. Known severe hypersensitivity to pre-medications required for treatment with
pemetrexed / cisplatin or pemetrexed/carboplatin doublet chemotherapy

4. Absolute neutrophil counts (ANC) less than 2.0 x 109/L (2,000/mm3), platelets less
than 100 x 109/L (100,000/mm3) or haemoglobin less than 10 g/dl

5. Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline

6. Serum bilirubin is greater than 1.5 times the upper limit of reference range

7. Serum creatinine is greater than 1.5 times the ULRR

8. Unable to tolerate pemetrexed/ cisplatin or pemetrexed/carboplatin doublet
chemotherapy, as judged by the investigator.