Phase 3 Lung Cancer Trial, Not Yet Recruiting NCT06581380 Sponsor: JenKem Technology Co., Ltd. Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Not Yet Recruiting

NCT06581380
Not Yet Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are willing to sign and date a consent form before any study-related screening procedures begin.
  • People who are 18 to 70 years old (male or female).
  • People whose small cell lung cancer (a type of lung cancer) has been confirmed through a tissue or cell sample test.
  • People who have received only one previous platinum-based chemotherapy treatment for advanced (extensive-stage) small cell lung cancer, and whose cancer has continued to grow or come back within 6 months of finishing that treatment.
  • People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1).
  • People who have a good general level of physical functioning, scored at 0 or 1 on a standard scale used by doctors to assess daily activity ability (ECOG performance status).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with a known allergy or sensitivity to any ingredient in the study drug JK-1201I or to the drug Topotecan.
  • People who have previously been treated with a type of chemotherapy drug known as a DNA topoisomerase I inhibitor.
  • People who have received two or more lines of chemotherapy or systemic treatment for advanced (extensive-stage) small cell lung cancer.
  • People who have had chemotherapy within 4 weeks before starting the study drug, limited-area radiotherapy for symptom relief within 2 weeks before starting the study drug, or biological therapy drugs within 2 weeks before starting the study drug.
  • People who have had serious gastrointestinal (digestive system) illness in the 6 months before starting the study drug (as defined by the trial protocol).
  • People whose tumour is causing local symptoms that require radiotherapy or surgery to manage (as defined by the trial protocol).
  • People who have untreated or currently active brain metastases (cancer that has spread to the brain), with some exceptions as defined by the trial protocol (confirm with trial site).
  • People who have had serious lung illness in the 6 months before starting the study drug.
  • People with uncontrolled fluid build-up around the lungs or in the abdomen.
  • People who still have significant side effects from previous cancer treatments that have not recovered to a mild level, with some exceptions as defined by the trial protocol (confirm with trial site).
  • People who have had a serious infection within 4 weeks before starting the study drug.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026

Contact this trial

Phone: 8610-82156767

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
JenKem Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
16 September 2024
Est. completion
16 November 2027

Primary endpoints

Overall survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov