Patients were stratified according to Asian or non-Asian race and were randomly assigned in a 2:1 ratio to receive oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles. Patients without disease progression after four cycles of platinum therapy plus pemetrexed (platinum–pemetrexed group) could continue maintenance pemetrexed according to the approved label.
Treatment continued until disease progression, the development of unacceptable side effects, or a request by either the patient or the physician to discontinue treatment. Patients could receive the trial treatment beyond the point of disease progression (as defined according to the Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) as long as they were receiving clinical benefit, as judged by the investigator.
According to an amendment to the protocol on December 22, 2014, patients who had been assigned to receive platinum–pemetrexed could cross over to the osimertinib group after objective disease progression, according to investigator assessment and as confirmed by blinded independent central review. All the patients provided written informed consent before screening.
Treatment continued until disease progression, the development of unacceptable side effects, or a request by either the patient or the physician to discontinue treatment. Patients could receive the trial treatment beyond the point of disease progression (as defined according to the Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) as long as they were receiving clinical benefit, as judged by the investigator.
According to an amendment to the protocol on December 22, 2014, patients who had been assigned to receive platinum–pemetrexed could cross over to the osimertinib group after objective disease progression, according to investigator assessment and as confirmed by blinded independent central review. All the patients provided written informed consent before screening.
