Status:
NOT_YET_RECRUITING
JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
JenKem Technology Co., Ltd.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- Participants must meet all the following criteria to be eligible for randomization into the study:
- 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).
- Has at least 1 measurable lesion according to RECIST v1.1.
- Has ECOG PS of ≤1.
Exclusion
- Participants who meet any of the following criteria will be disqualified from entering the study:
- 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.
- Severe gastrointestinal illnesses as defined in the protocol within 6 months before the first use of the study drug.
- Local symptoms of tumors requiring radiotherapy or surgical treatment as defined in the protocol.
- Untreated or symptomatic brain metastases with exceptions defined in the protocol.
- Severe pulmonary illnesses within 6 months before the first use of the study drug.
- Uncontrolled hydrothorax and ascites.
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
- Severe infections within 4 weeks before the first use of the study drug.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 16 2028
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT06581380
Start Date
September 16 2024
End Date
April 16 2028
Last Update
September 3 2024
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