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

NCT ID: NCT06581380

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2028-04-16

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JK-1201I

Intervention Type: DRUG

JK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle.

Topotecan

Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.

Group Type: ACTIVE_COMPARATOR

Topotecan

Intervention Type: DRUG

Topotecan will be administered per drug label.

Interventions

JK-1201I

JK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Topotecan

Topotecan will be administered per drug label.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JenKem Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yahui SU

Role: CONTACT

yahuisu@jenkem.com

8610-82156767

Other Identifiers

JK-1201I-301

Identifier Type: -

Identifier Source: org_study_id