① Disease control rate (ORR plus stable disease according to RECIST 1.1)
② Duration of response (time from date of first response to the date of disease progression, relapse, or death)
③ Progression-free survival (time from the date of first infusion to disease progression or death from any cause)
④ Overall survival (time from the date of first infusion to death or loss to follow-up)
⑤ Evaluate the safety and tolerability of Lurbinectedin (투약 후 발생 이상사례를 NCI-CTC AE v5.0을 사용하여 빈도, 중증도, 중대성 및 관련성 확인)
⑥ Biomarker should be identified by statistical methods for correlation between disease control rates, response duration, progression-free survival, and overall survival.
- Radiological assessment (CT scan or MRI) was done every 6 weeks (two cycles) until cycle 6, and every 9 weeks (three cycles) thereafter according to RECIST 1.1
- Objective response was to be confirmed at least 4 weeks later
