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Trial Title:
JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
NCT ID:
NCT06581380
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JK-1201I
Description:
JK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each
21-day cycle.
Arm group label:
JK-1201I
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan will be administered per drug label.
Arm group label:
Topotecan
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants must meet all the following criteria to be eligible for randomization into
the study:
1. Sign and date the informed consent form prior to the start of any study-specific
qualification procedures.
2. Male or female aged ≥18 years and ≤70 years.
3. Histologically or cytologically documented SCLC.
4. 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).
5. Has at least 1 measurable lesion according to RECIST v1.1.
6. Has ECOG PS of ≤1.
Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering
the study:
1. Hypersensitivity to any ingredient of JK-1201I and Topotecan.
2. Has received prior treatment with DNA topoisomerase I inhibitor agents.
3. Has received prior therapy with ≥2 line as systemic therapy for extensive-stage
SCLC.
4. 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.
5. Severe gastrointestinal illnesses as defined in the protocol within 6 months before
the first use of the study drug.
6. Local symptoms of tumors requiring radiotherapy or surgical treatment as defined in
the protocol.
7. Untreated or symptomatic brain metastases with exceptions defined in the protocol.
8. Severe pulmonary illnesses within 6 months before the first use of the study drug.
9. Uncontrolled hydrothorax and ascites.
10. 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.
11. Severe infections within 4 weeks before the first use of the study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 16, 2024
Completion date:
April 16, 2028
Lead sponsor:
Agency:
JenKem Technology Co., Ltd.
Agency class:
Industry
Source:
JenKem Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06581380
