NCT06581380

JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer

A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: JenKem Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	JK-1201I	JK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle.
DRUG	Topotecan	Topotecan will be administered per drug label.

Timeline

• Start date: 2024-09-16
• Primary completion: 2027-11-16
• Completion: 2028-04-16
• First posted: 2024-09-03
• Last updated: 2024-09-03