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).
This is a multicenter, randomized, positive-controlled, open-label, phase 3 study comparing JK-1201I with topotecan in patients with Relapsed Extensive Stage Small Cell Lung Cancer that had relapsed or disease progression on or after platinum-based first-line chemotherapy. Patients will be randomized by a ratio of 1:1 to receive JK-1201I or topotecan until disease progression. of JK-1201I Compared with Topotecan in Patients With Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy The primary objective of this study is to assess whether treatment with JK-1201I prolongs overall survival (OS) compared with treatment of topotecan among patients with relapsed ES SCLC. The secondary objectives of the study are to further evaluate the efficacy, safety and population pharmacokinetics of JK-1201I.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
394
Overall survival (OS)
Overall survival is defined as the time interval from randomization to death due to any cause.
Time frame: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.
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.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.
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.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.
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.
Time frame: From the date of first documentation of confirmed response (CR or PR) to the first documentation of progressive disease or death due to any cause, whichever occurs first; Up to approximately 3.5 years.
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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.
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.
Incidence and Grade of Participants with Adverse Events (AE)
Adverse Events (AEs) are assessed based on NCI CTCAE v5.0.
Time frame: From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using Non-linear mixed effect modeling in 80 participants randomized to JK-1201 group.
Time frame: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling in 80 participants randomized to JK-1201 group.
Time frame: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)