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

Sponsor
JenKem Technology Co., Ltd.
Study ID
NCT06581380
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Sep 3, 2024
Start date
Sep 16, 2024
Status verified
Aug 2024
Primary completion
Nov 16, 2027
Completion
Apr 16, 2028

Study Design

Enrollment
394 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JK-1201I
    Participants will receive JK-1201I as an intravenous (IV) infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.
  • Active Comparator: Topotecan
    Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years. ]

Central Contacts

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