Relapsed Small Cell Lung CancerPhase 3NCT06128837
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
A Phase 3 study testing Irinotecan hydrochloride liposome Injection and Topotecan in people with Relapsed Small Cell Lung Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapsed Small Cell Lung Cancer
- What is being tested?
- Irinotecan hydrochloride liposome Injection and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2024to Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female;
- Patients with histologically and/or cytologically confirmed small cell lung cancer;
- Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery;
- At least one evaluable lesion (according to RECIST 1.1 criteria);
- Expected survival time ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) score < 2;
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- Patients who received no liver metastasis; or the number of liver metastases was ≤ 3 and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longest diameter of a single lesion was > 1.5 cm, the imaging was stable for at least 3 weeks after local treatment control;
- Patients with brain metastasis at baseline should meet all the following conditions: lesions not involving the brainstem, the number of brain metastases ≤ 2 (but patients with only intracranial target lesions should be excluded), imaging stability for at least 3 weeks after local treatment control, and no application of dehydration drugs and hormones before screening,Without any symptoms of brain metastasis;
- Organ function meeting the following criteria at screening: a.Blood routine: neutrophil (ANC) ≥ 1.5 × 109/L, platelet (PLT) ≥ 100 × 109/L, hemoglobin (Hb) ≥ 90 g/L; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g/L; c.Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min; d.Coagulation function: Prothrombin time - international normalized ratio (PT-INR) < 1.5;
- Has fully understood and voluntarily signed a written informed consent form for this study and is able to comply with the requirements and restrictions listed in the informed consent form;
- Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to use reliable contraceptive measures during the study and within 6 months after the infusion of study drug.
Who cannot join
- Pathological diagnosis of compound small cell lung cancer;
- Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;
- Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy/surgery/endoscopic therapy/intervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and/or pericardial effusion with local treatment and unstable control;
- Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;
- Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,
- Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis; Patients with severe gastrointestinal diseases or gastrointestinal disorders (such as gastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immune enteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis, diarrhea > grade 1, other gastrointestinal diseases that may affect the tolerance of chemotherapy) at screening;
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- Patients with the following cardiovascular and cerebrovascular diseases or history:
- patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis or hypertensive encephalopathy;
- patients with unstable severe arrhythmia;
- patients with the following cardiovascular and cerebrovascular diseases within 6 months: myocardial infarction, unstable angina, coronary revascularization/angioplasty, coronary artery bypass grafting, coronary artery stenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history, active cerebral infarction, active cerebral hemorrhage;
- Patients with any of the following conditions:
- positive hepatitis B virus surface antigen (HBsAg) test,And peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU/mL;
- hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleic acid (HCV-RNA) detection ≥ 100 IU/mL;
- human immunodeficiency virus antibody (HIV-Ab) detection positive;
- Other malignancies within 5 years before screening (except cured stage IB or lower cervical cancer, non-invasive basal cell, scale-cell skin cancer or resectable carcinoma in situ);
- Patients with primary diseases of other important organs (such as nervous system, cardiovascular and cerebrovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system diseases) and the researchers believe that it is not suitable for participants, or for other reasons the researchers believe that it is not suitable for participants;
- Previous treatment with irinotecan or irinotecan modified, topotecan or other topoisomerase I inhibitors;
- Known hypersensitivity to irinotecan hydrochloride liposomes or its excipients, structurally similar compounds (such as camptothecin compounds), other liposomal drugs, and topotecan;
- Those who have been vaccinated with live vaccine or live attenuated vaccine before screening;
- Patients who have received systemic anti-tumor therapy in 4 weeks before randomization;
- Patients who have applied other clinical trial drugs/devices before randomization;
- Patients who have used strong inducers or strong inhibitors of CYP3A4 and strong inhibitors of UGT1A1 before randomization;
- Adverse reactions caused by previous anti-tumor treatment are not recovered to grade 1 or lower (except alopecia and peripheral neuropathy);
- History of drug abuse, drug abuse and/or alcoholism;
- Pregnant or lactating women;
- Other conditions (including but not limited to unstable nervous system diseases and mental disorders) that are considered unsuitable for inclusion in this trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)
This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)
Read the detailed description
A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.
- Conditions
- Relapsed Small Cell Lung Cancer
- Being tested
- Irinotecan hydrochloride liposome Injection, 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.
Irinotecan hydrochloride liposome InjectionDrug
Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk
TopotecanDrug
Topotecan 1.2 mg/m² intravenously Days 1-5 q3w
| Study group | Role | What they receive |
|---|---|---|
| LY01610 | Experimental | Patients will consecutively receive LY01610 on Day 1 q2wk (every two weeks = one treatment cycle) Receives: Drug: Irinotecan hydrochloride liposome Injection |
| Topotecan | Active comparator | Patients will consecutively receive Topotecan on Days 1-5 q3wk(every three weeks = one treatment cycle) 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 from randomization to date of death.
Measured: From the date of randomization to the date of death or last contact, whichever occurs first, assessed up to 52 month
Secondary outcomes (11)
Progression-free survival (PFS)
Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first
Measured: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, whichever occurs first, assessed up to 52 months
Overall response rate
Overall response rate (ORR) will be the best response obtained in any evaluation according to RECIST v.1.1
Measured: At baseline and every six weeks (± one week) through study completion, an average of 1 year
Overall survival rate at 1 year
Overall survival rate at 1 year is defined as the percentage of people who are still alive at 12 months after randomization.
Measured: At 12 months
Duration of response
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death
Measured: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, whichever occurs first, assessed up to 52 months
Patient-reported outcomes
To measure the quality of life of patients, EORTC QLQ-C30/LC13 questionnaire will be analyzed
Measured: At baseline and every six weeks (± one week) through study completion, an average of 1 year
Maximum plasma concentration
Maximum plasma concentration of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (Cmax) in 20~24 subjects treated with LY01610
Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Time to maximum plasma concentration
Time to maximum plasma concentration of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (Tmax) in 20~24 subjects treated with LY01610
Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve of total Irinotecan，free Irinotecan ，and its metabolite SN-38，SN-38G (AUC) in 20~24 subjects treated with LY01610
Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Elimination half-life
Elimination half-life of total Irinotecan，free Irinotecan，and its metabolite SN-38，SN-38G (t1/2) in 20~24 subjects treated with LY01610
Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Plasma concentrations for Population PK Analyses
Pharmacokinetic plasma concentration-time data for total Irinotecan，free Irinotecan，and its metabolite SN-38，SN-38G will be analyzed using population pharmacokinetic methods in all subjects treated with LY01610 and identify the effect of covariates on pharmacokinetic parameters in the subject population
Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities
Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any study drug
Measured: From the date of randomization through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Mar 2024
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yuankai shi, doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128837
- Sponsor's protocol ID
- LY01610/CT-CHN-304
- Status last verified
- Mar 2024
- First submitted
- 18 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT06128837
- Acronym / sponsor ID
- LY01610/CT-CHN-304
- Conditions
- Relapsed Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Nov 2023 (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 a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)
Detailed description
A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY01610 | Experimental | Drug: Irinotecan hydrochloride liposome InjectionPatients will consecutively receive LY01610 on Day 1 q2wk (every two weeks = one treatment cycle) |
| Topotecan | Active comparator | Drug: TopotecanPatients will consecutively receive Topotecan on Days 1-5 q3wk(every three weeks = one treatment cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years, male or female;
- Patients with histologically and/or cytologically confirmed small cell lung cancer;
- Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery;
- At least one evaluable lesion (according to RECIST 1.1 criteria);
- Expected survival time ≥ 3 months;
Key exclusion criteria (26 listed)
- Pathological diagnosis of compound small cell lung cancer;
- Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;
- Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy/surgery/endoscopic therapy/intervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and/or pericardial effusion with local treatment and unstable control;
- Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;
- Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,
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 |
|---|---|---|
| Irinotecan hydrochloride liposome InjectionIrinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk | Drug | LY01610 |
| TopotecanTopotecan 1.2 mg/m² intravenously Days 1-5 q3w | Drug | Topotecan |
Primary outcome
Overall survival (OS)
Time frame: From the date of randomization to the date of death or last contact, whichever occurs first, assessed up to 52 month
Overall survival is defined as the time from randomization to date of death.
11 secondary outcomes
Progression-free survival (PFS)
Time frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, whichever occurs first, assessed up to 52 months
Overall response rate
Time frame: At baseline and every six weeks (± one week) through study completion, an average of 1 year
Overall survival rate at 1 year
Time frame: At 12 months
Duration of response
Time frame: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, whichever occurs first, assessed up to 52 months
Patient-reported outcomes
Time frame: At baseline and every six weeks (± one week) through study completion, an average of 1 year
Maximum plasma concentration
Time frame: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Time to maximum plasma concentration
Time frame: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Area under the plasma concentration-time curve
Time frame: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Elimination half-life
Time frame: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Plasma concentrations for Population PK Analyses
Time frame: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）
Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities
Time frame: From the date of randomization through study completion, an average of 1 year
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 15 Mar 2024.
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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.
yuankai shi, doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irinotecan hydrochloride liposome Injection and Topotecan in people with Relapsed Small Cell Lung Cancer, run by Luye Pharma Group 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 11 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 15 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 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 yuankai shi, doctor (8610-87788293, syuankaipumc@126.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 or last contact, whichever occurs first, assessed up to 52 month). 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 15 Mar 2024.