NCT06581380Not yet recruitingPhase 3
JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- First submitted
- 29 Aug 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 16 Nov 2027
- Lead sponsor
- JenKem Technology Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06581380
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 394
- From 16 Sept 2024 to the primary completion date, 16 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Severe pulmonary illnesses within 6 months before the first use of the study drug.
- 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.
Other illness
- Hypersensitivity to any ingredient of JK-1201I and Topotecan.
Other
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Untreated or symptomatic brain metastases with exceptions defined in the protocol.
- Uncontrolled hydrothorax and ascites.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.