Small Cell Lung CancerPhase 2NCT04352413
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
A Phase 2 study testing PLM60 in people with Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60 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?
- PLM60
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2020to 29 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologically confirmed diagnosis of SCLC;
- Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
- ECOG performance status 0~2;
- Measurable lesion according to RECIST v1.1;
- Life expectancy ≥ 12 weeks;
- Adequate organ function;
- Signed informed consent from the patient.
Who cannot join
- Radical surgical treatment for primary small cell lung cancer;
- Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of >360 mg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60
- Conditions
- Small Cell Lung Cancer
- Being tested
- PLM60
- 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.
PLM60Drug
Administration: Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: PLM60 | Experimental | 20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle Receives: Drug: PLM60 |
| Cohort B: PLM60 | Experimental | 15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle Receives: Drug: PLM60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To evaluate ORR in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Secondary outcomes (6)
Duration of Response (DoR)
To evaluate DoR in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Disease Control Rate (DCR)
To evaluate DCR in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Progression Free Survival (PFS)
To evaluate PFS in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Overall Survival (OS)
To evaluate OS in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Adverse Events
To evaluate the safety profiles in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Serious Adverse Events (SAEs)
To evaluate the safety profiles in SCLC subjects treated with PLM60
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start18 Jun 2020
- Primary completion30 Jan 2022
- Study completion29 Apr 2022
Why it stopped: The sponsor has adjusted its R\&D strategy.
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.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kun Lou, Study chair, Department of Medicine, CSPC Clinical Development Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352413
- Sponsor's protocol ID
- HE071-CSP-010
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT04352413
- Acronym / sponsor ID
- HE071-CSP-010
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has adjusted its R\&D strategy.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 20 Apr 2020 (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 is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: PLM60 | Experimental | Drug: PLM6020 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle |
| Cohort B: PLM60 | Experimental | Drug: PLM6015mg/m2, 3 weeks/cycle, administered on day 1 of each cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of SCLC;
- Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
- ECOG performance status 0~2;
- Measurable lesion according to RECIST v1.1;
- Life expectancy ≥ 12 weeks;
Key exclusion criteria (7 listed)
- Radical surgical treatment for primary small cell lung cancer;
- Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- History of serious systemic diseases;
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 |
|---|---|---|
| PLM60Administration: Intravenous infusion | Drug | Cohort A: PLM60, Cohort B: PLM60 |
Primary outcome
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 year
To evaluate ORR in SCLC subjects treated with PLM60
6 secondary outcomes
Duration of Response (DoR)
Time frame: Through study completion, an average of 2 year
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 2 year
Progression Free Survival (PFS)
Time frame: Through study completion, an average of 2 year
Overall Survival (OS)
Time frame: Through study completion, an average of 2 year
Adverse Events
Time frame: Through study completion, an average of 2 year
Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 2 year
Results and safety
The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kun Lou study chair
Department of Medicine, CSPC Clinical Development Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLM60 in people with Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 7 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: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Through study completion, an average of 2 year). 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 7 Mar 2024.