This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).
Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Male or female aged ≥18 years and ≤70 years.
Histologically or cytologically documented SCLC.
Has received prior therapy with only one prior platinum-based line as systemic therapy for ES SCLC and Disease progression on or after first-line platinum-based regimens (≤ 6 months).
Hypersensitivity to any ingredient of JK-1201I and Topotecan.
Has received prior treatment with DNA topoisomerase I inhibitor agents.
Has received prior therapy with ≥2 line as systemic therapy for extensive-stage SCLC.
Chemotherapy-free interval within 4 weeks before the first use of the study drug. Radiotherapy with a limited field of radiation for palliation within 2 weeks before the first use of the study drug. Used biotherapy drugs within 2 weeks before the first use of the study drug.
Parallel
JK-1201I
DrugJK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle.
Topotecan
DrugTopotecan will be administered per drug label.
Overall survival (OS)
Overall survival is defined as the time interval from randomization to death due to any cause.
Objective Response Rate (ORR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
Confirmed ORR is defined as the proportion of participants who have achieved a best overall response of confirmed complete response (CR), confirmed partial response (PR) per IREC and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Disease Control Rate (DCR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per IREC and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Duration of Response (DoR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death.
Progression-free Survival (PFS) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression as per Independent Response Evaluation Committee (IREC) and Investigators assessment or death due to any cause.
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