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

Launched by JENKEM TECHNOLOGY CO., LTD. · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare a new treatment called JK-1201I with an existing medication called Topotecan for patients who have relapsed extensive stage small cell lung cancer (ES SCLC). The main goal is to see which treatment works better and is safer for patients whose cancer has returned after previous treatment. The study is not yet recruiting participants, but it will include adults aged 18 to 70 who have been diagnosed with small cell lung cancer and have only received one prior type of chemotherapy that contains platinum.

To participate in this trial, patients must be in reasonably good health, meaning they should have at least one measurable tumor and not have severe health issues that could complicate treatment. Participants will need to sign a consent form and will be closely monitored throughout the study to evaluate the effectiveness and safety of the treatments. It's important to note that certain people will not be eligible, such as those who have had multiple prior treatments or specific health problems. Overall, this study aims to provide insights into better treatment options for individuals facing this challenging condition.

Gender

ALL

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.