Clinical trial NCT06581380: JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Lead sponsor: JenKem Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.
Secondary outcomes:
measure: Objective Response Rate (ORR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
timeFrame: 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.
measure: Disease Control Rate (DCR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
timeFrame: 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.
measure: Duration of Response (DoR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
timeFrame: 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.
measure: Progression-free Survival (PFS) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
timeFrame: 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.
measure: Incidence and Grade of Participants with Adverse Events (AE)
timeFrame: From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years
measure: Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
timeFrame: 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)
measure: Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
timeFrame: 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)
Other outcomes:
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