JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
NCT Number: NCT06581380
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Small Cell Lung Cancer
Sponsor: JenKem Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 394
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2028-04-16

Summary:
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).

Primary Outcome Measures: Overall survival (OS), Overall survival is defined as the time interval from randomization to death due to any cause., From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.
Secondary Outcome Measures: 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., 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., 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., 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.|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., 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., 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., 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., 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)