Small Cell Lung CancerPhase 3NCT06581380
JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer
A Phase 3 study testing JK-1201I and Topotecan in people with Small Cell Lung Cancer, run by JenKem Technology Co., Ltd..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- JK-1201I and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2024to 16 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
Read the 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
- Being tested
- JK-1201I, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK-1201IDrug
JK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle.
TopotecanDrug
Topotecan will be administered per drug label.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JK-1201I |
| Topotecan | Active comparator | Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol. Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival is defined as the time interval from randomization to death due to any cause.
Measured: 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
Confirmed ORR is defined as the proportion of participants who have achieved a best overall response of confirmed complete response (CR), confirmed partial response (PR) per IREC and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measured: 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
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per IREC and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measured: 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
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death.
Measured: 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
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression as per Independent Response Evaluation Committee (IREC) and Investigators assessment or death due to any cause.
Measured: 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)
Adverse Events (AEs) are assessed based on NCI CTCAE v5.0.
Measured: From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using Non-linear mixed effect modeling in 80 participants randomized to JK-1201 group.
Measured: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling in 80 participants randomized to JK-1201 group.
Measured: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 Sep 2024 (estimated)
- Primary completion16 Nov 2027 (estimated)
- Study completion16 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JenKem Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581380
- Sponsor's protocol ID
- JK-1201I-301
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06581380
- Acronym / sponsor ID
- JK-1201I-301
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- JenKem Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- 16 Nov 2027 (estimated)
- Study completion
- 16 Apr 2028 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JK-1201I | Experimental | Drug: JK-1201IParticipants 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. |
| Topotecan | Active comparator | Drug: TopotecanParticipants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JK-1201IJK-1201I will be administered as an IV infusion at dose of 180mg/m2 on Day 1 of each 21-day cycle. | Drug | JK-1201I |
| TopotecanTopotecan will be administered per drug label. | Drug | Topotecan |
Primary outcome
Overall survival (OS)
Time frame: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.
Overall survival is defined as the time interval from randomization to death due to any cause.
7 secondary outcomes
Objective Response Rate (ORR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G
Time frame: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Time frame: Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JK-1201I and Topotecan in people with Small Cell Lung Cancer, run by JenKem Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahui SU (8610-82156767, yahuisu@jenkem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.