Small Cell Lung CancerPhase 2NCT04381910
Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer
A Phase 2 study testing LY01610( Irinotecan hydrochloride liposome injection ) in people with Small Cell Lung Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that Progressed after first-line Antitumor Therapy. 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?
- LY01610( Irinotecan hydrochloride liposome injection )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2020to 4 Mar 2023
- 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
- 1.Male or female patients aged 18 to 70 years (18 years and 70 years are inclusive).
- 2.Histologically or cytologically confirmed extensive small cell lung cancer. 3.Disease progression or recurrence after one prior systematic anti-tumor treatment regimen (including platinum-containing chemotherapy, etc.; with or without radiotherapy).
- 4.The patient should have at least one measurable lesion (according to RECIST 1.1 criteria).
- 5.Life expectancy ≥3 months. 6.The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 to 1 point.
- 7.Laboratory results during screening:
- Hematology：Absolute neutrophil count ≥ 1.5× 109/L, platelet count≥ 100× 109/L and hemoglobin≥ 90 g/L.
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- Liver function: Total bilirubin <1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN for the subjects without liver metastasis; ALT and AST≤5×ULN for the subjects with liver metastasis.
- Kidney function: Serum creatinine ≤ 1.5 ×ULN or creatinine clearance rate ≥ 50 mL/min.
- Coagulative function: Prothrombin time - international standardized ratio（PT-INR） <1.5.
- 8.The subject has voluntarily signed the written informed consent form (ICF) and can comply with the study protocol.
- 9.The female subjects and male subjects of childbearing age and the partners of the male subjects agree to take reliable contraceptive measures (such as abstinence, sterilizing operation, contraceptives, injection of the contraceptive drug medroxyprogesterone acetate or subdermal implant of contraceptives) during the study period and within 6 months after infusion of the study drugs.
Who cannot join
- 1.Patients with the symptomatic brain metastasis, meningeal metastases, spinal cord tumor invasion, spinal cord compression. Patients with superior vena cava syndrome, obstructive atelectasis and bone metastasis who have local symptoms, which may require radiotherapy / surgery / endoscopic treatment / interventional treatment and other non-medical treatment.
- 2.Patients have other malignant tumors within 5 years(except for cured stage ⅠB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer) 3.Uncontrolled massive hydrothorax, ascites and pericardial effusion. 4.Patients have history of deep vein thrombosis or pulmonary embolism. 5.The patient with persistent or active infection signs which need intravenous injection of antibiotics.
- 6.Medical history of the following diseases within 6 months: myocardial infarction, unstable angina pectoris, coronary revascularization, cardiac dysfunction (New York heart association (NYHA) grade ≥ II), severe unstable ventricular arrhythmia or arrhythmias that need to be treated at the time of screening.
- 7.The patient with Active hepatitis B: hepatitis B surface antigen (HBsAg) positive and the peripheral blood hepatitis B virus DNA (HBV DNA)titer ≥1× 103 copies/mL or 200 IU/ml. The subject is eligible to be enrolled if HBsAg is positive and peripheral blood HBV DNA titer <1×103 copies/mL or 200 IU/ml and the investigator considers that the subject is at the stable stage of chronic hepatitis and the risk will not be increased for the subject. The patient with hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive and active syphilis infection.
- 8.Patients have severe gastrointestinal disorders (such as gastrointestinal bleeding, infection, chronic enteritis, obstruction, or diarrhea with CTCAE grade 1 or higher) at the time of screening.
- 9.Patients with medical history of neuropathy or mental disorder (including epilepsy or dementia).
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- 10.Patients have been or are suffering from bronchial asthma, interstitial lung disease or active hemoptysis within 6 months.
- 11.Patients with primary diseases of other major organs (such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system) and the investigators believe that it is not suitable for enrollment, or for other reasons the investigators don't think that suitable for inclusion.
- 12.Patients who have previous treatment with irinotecan or immunotherapy. 13.Known hypersensitivity to any of the components of irinotecan liposome injection, other structurally similar compounds (such as camptothecins), or other liposomal products.
- 14.Patients have participated in other pharmaceutical clinical trial within one month before screening.
- 15.Patients have received systemic antitumor therapy such as radiation, chemotherapy, immunotherapy or other treatments within 4 weeks prior to start of therapy.
- 16.Patients have received live or attenuated vaccines within one month prior to the screening.
- 17.Use of strong CYP3A4 inducers (phenytoin or carbamazepine, barbiturates, rifampin, rifabutin or rifapentine, hypericum perforatum, etc) during or within 14 days prior to starting study medication.
- 18.Use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole or itraconazole, indinavir, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir,voriconazole, etc) during or within 14 days prior to starting study medication. 19.Use of strong UGT1A1 inhibitors during or within 14 days prior to starting study medication (atazanavir, gemfibrozil, indinavir, etc.).
- 20.Patients who are taking or may take drugs that reduce cholinesterase activity or choline drugs (neostigmine, lissamine, acetylcholine, etc.).
- 21.Patients may used the skeletal muscle relaxation drugs (such as succinylcholine) during the trial.
- 22.The patient who has drug and/or alcohol abuse. 23.Pregnant or lactating women. 24.Patients who did not take contraceptive measures during the trial. 25.Other circumstances which are considered by the investigator that the subject is unsuitable to be enrolled.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official title: A Phase Ⅱ Study Evaluate the Efficacy and Safety of LY01610（Irinotecan Hydrochloride Liposome Injection） in Patients With Small Cell Lung Cancer
This is a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that Progressed after first-line Antitumor Therapy.
Read the detailed description
The objectives are to evaluate the efficacy and safety of LY01610 in subjects with extensive small cell lung cancer that progressed after first-line antitumor therapy.
Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study.
- Conditions
- Small Cell Lung Cancer
- Being tested
- LY01610( Irinotecan hydrochloride liposome injection )
- Keywords
- LY01610, Efficacy, Safety, Irinotecan Hydrochloride Liposome Injection, Second-Line Therapy
- 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.
LY01610( Irinotecan hydrochloride liposome injection )Drug
LY01610 will be administered via intravenous infusion every 2 weeks on Day 1
| Study group | Role | What they receive |
|---|---|---|
| LY01610 | Experimental | LY01610(Irinotecan Hydrochloride Liposome Injection),Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study. Receives: Drug: LY01610( Irinotecan hydrochloride liposome injection ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Duration of Response(DoR)
Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Secondary outcomes (3)
Disease Control Rate(DCR)
Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Progression Free Survival(PFS)
Measured: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Overall Survival(OS)
Measured: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start28 Sep 2020
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Professor, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381910
- Sponsor's protocol ID
- LY01610/CT-CHN-202
- Status last verified
- Apr 2024
- First submitted
- 6 May 2020
- Last updated
- 25 Apr 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study Evaluate the Efficacy and Safety of LY01610（Irinotecan Hydrochloride Liposome Injection） in Patients With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04381910
- Acronym / sponsor ID
- LY01610/CT-CHN-202
- Conditions
- Small Cell Lung Cancer
- Keywords
- LY01610, Efficacy, Safety, Irinotecan Hydrochloride Liposome Injection, Second-Line Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 11 May 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 a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that Progressed after first-line Antitumor Therapy.
Detailed description
The objectives are to evaluate the efficacy and safety of LY01610 in subjects with extensive small cell lung cancer that progressed after first-line antitumor therapy.
Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY01610 | Experimental | Drug: LY01610( Irinotecan hydrochloride liposome injection )LY01610(Irinotecan Hydrochloride Liposome Injection),Patients were enrolled in one to three cohorts to receive LY01610 every 2 weeks, initial 30 subjects will be included in each cohort and the number of the cases could be adjusted. Subjects will receive LY01610 start with 60 mg/m2 every 2 weeks，when the sixth subjects of the current cohort completed 14 days safety observation of the first LY01610 administration, the investigators will evaluate the ongoing dose tolerance. If the investigator and the sponsor jointly believe that other doses can provide greater potential benefits for patients while ensuring safety and benefit, other appropriate cohorts could be explored (such as 80, 90 and 100 mg/m2, etc.) Subjects will receive the LY01610 monotherapy until occurrence of progressive disease (PD), death, intolerable toxicity reaction, withdrawal of informed consent, conduct of other antitumor therapy or completion of the whole study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1.Male or female patients aged 18 to 70 years (18 years and 70 years are inclusive).
- 2.Histologically or cytologically confirmed extensive small cell lung cancer. 3.Disease progression or recurrence after one prior systematic anti-tumor treatment regimen (including platinum-containing chemotherapy, etc.; with or without radiotherapy).
- 4.The patient should have at least one measurable lesion (according to RECIST 1.1 criteria).
- 5.Life expectancy ≥3 months. 6.The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 to 1 point.
- 8.The subject has voluntarily signed the written informed consent form (ICF) and can comply with the study protocol.
Key exclusion criteria (17 listed)
- 1.Patients with the symptomatic brain metastasis, meningeal metastases, spinal cord tumor invasion, spinal cord compression. Patients with superior vena cava syndrome, obstructive atelectasis and bone metastasis who have local symptoms, which may require radiotherapy / surgery / endoscopic treatment / interventional treatment and other non-medical treatment.
- 2.Patients have other malignant tumors within 5 years(except for cured stage ⅠB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer) 3.Uncontrolled massive hydrothorax, ascites and pericardial effusion. 4.Patients have history of deep vein thrombosis or pulmonary embolism. 5.The patient with persistent or active infection signs which need intravenous injection of antibiotics.
- 6.Medical history of the following diseases within 6 months: myocardial infarction, unstable angina pectoris, coronary revascularization, cardiac dysfunction (New York heart association (NYHA) grade ≥ II), severe unstable ventricular arrhythmia or arrhythmias that need to be treated at the time of screening.
- 7.The patient with Active hepatitis B: hepatitis B surface antigen (HBsAg) positive and the peripheral blood hepatitis B virus DNA (HBV DNA)titer ≥1× 103 copies/mL or 200 IU/ml. The subject is eligible to be enrolled if HBsAg is positive and peripheral blood HBV DNA titer <1×103 copies/mL or 200 IU/ml and the investigator considers that the subject is at the stable stage of chronic hepatitis and the risk will not be increased for the subject. The patient with hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive and active syphilis infection.
- 8.Patients have severe gastrointestinal disorders (such as gastrointestinal bleeding, infection, chronic enteritis, obstruction, or diarrhea with CTCAE grade 1 or higher) at the time of 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 |
|---|---|---|
| LY01610( Irinotecan hydrochloride liposome injection )LY01610 will be administered via intravenous infusion every 2 weeks on Day 1 | Drug | LY01610 |
Primary outcome
Objective Response Rate(ORR)
Time frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Duration of Response(DoR)
Time frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
3 secondary outcomes
Disease Control Rate(DCR)
Time frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Progression Free Survival(PFS)
Time frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Overall Survival(OS)
Time frame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
Yuankai Shi, Professor principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
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 LY01610( Irinotecan hydrochloride liposome injection ) in people with 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 17 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: finished, as of the sponsor's last update on 25 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject). The study lists 2 primary outcomes in all. 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 25 Apr 2024.