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

NCT06581380 | Not Yet Recruiting Phase 3

• 1 other identifier: JK-1201I-301
• Study Type: interventional
• Target: 394
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival is defined as the time interval from randomization to death due to any cause.

  From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.

Secondary Outcomes (7)

• Objective Response Rate (ORR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators

  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.

• Disease Control Rate (DCR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators

  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.

• Duration of Response (DoR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators

  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.

• Progression-free Survival (PFS) Assessed by Independent Response Evaluation Committee (IREC) and Investigators

  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.

• Incidence and Grade of Participants with Adverse Events (AE)

  From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years

Study Arms (2)

JK-1201I

EXPERIMENTAL

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.

Drug: JK-1201I

Topotecan

ACTIVE COMPARATOR

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

Drug: Topotecan

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.

JK-1201I

Topotecan DRUG

Topotecan will be administered per drug label.

Topotecan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JenKem Technology Co., Ltd.: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Yahui SU

CONTACT

8610-82156767; yahuisu@jenkem.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): November 16, 2027
• Study Completion (Estimated): April 16, 2028
• Last Updated: September 3, 2024

Record last verified: 2024-08