Small Cell Lung CancerPhase 4NCT06467786
Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer
A Phase 4 study testing Irinotecan hydrochloride liposome injection in people with Small Cell Lung Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Irinotecan hydrochloride liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 15 Sep 2028
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF).
- Age ≥ 18 years old;
- Patients with extensive stage small cell lung cancer diagnosed by pathology or histology;
- According to RECIST 1.1 standard, patients have at least one measurable target lesion; For lesions that have undergone radiation therapy in the past, they can only be included as measurable lesions if there is clear disease progression after radiation therapy;
- Progression confirmed by imaging examination after 6 months of first-line radiotherapy and chemotherapy containing platinum drugs or platinum regimen radiotherapy and chemotherapy ± immunotherapy;
- Eastern Cancer Collaborative Group (ECOG) physical fitness score: 0-2 points;
Show all 10Show fewer
- Estimated survival time ≥ 3 months;
- Absolute neutrophil count (ANC) ≥ 1.5 x 10 ^ 9/L, platelet count ≥ 90 x 10 ^ 9/L, and hemoglobin count ≥ 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination);
- Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
- Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial period and 6 months after the last administration of the trial drug;
Who cannot join
- Patients with large cell neuroendocrine tumors and mixed small cell carcinoma;
- Patients with active brain metastasis or central nervous system invasion confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥ 10mg);
- There is an hypersensitivity reaction to any investigational drug or its components;
- Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
- Heart function and disease meet one of the following conditions:
- Long QTc syndrome or QTc interval>480 ms;
Show all 16Show fewer
- Complete left bundle branch block, II or III degree atrioventricular block;
- Severe and uncontrolled arrhythmias that require medication treatment;
- The New York College of Cardiology has a classification of ≥ III;
- Cardiac ejection fraction (LVEF) below 50%;
- A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment.
- Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL);
- Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
- Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years);
- Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures;
- Patients with other malignant tumors that require treatment; The researchers determined that patients who are not suitable to participate in this study.
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
Tangdu Hospital
Xi'an, Shannxi, 710038
Haichuan Su, PhD, 18629190366, such@fmmu.edu.cn
Jie Min, PhD, 13709202616, minjie1504@163.com
About this study
Official title: The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer
This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.
Read the detailed description
Based on literature research and the birth of independently developed irinotecan liposomes by Shiyao, we plan to conduct a therapeutic study on the combination of irinotecan liposomes and cisplatin/carboplatin for platinum sensitive recurrent small cell lung cancer. The aim is to explore the efficacy and safety of the combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line treatment of small cell lung cancer patients who have progressed after 6 months using platinum based regimens, providing better clinical evidence for use.
The research unit is the Second Affiliated Hospital of Air Force Military Medical University. The study includes screening period (within 28 days), treatment period, and follow-up period (safety follow-up and PFS follow-up). The subjects signed an informed consent form and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety, tolerance, and efficacy. The same subject only received one dosing plan during the study period. After the treatment period ends, enter the follow-up period.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Irinotecan hydrochloride liposome injection
- Keywords
- Small Cell Lung Cancer, Platinum sensitive, Irinotecan liposomes, 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.
Irinotecan hydrochloride liposome injectionDrug
Irinotecan hydrochloride liposome injection combined with platinum
| Study group | Role | What they receive |
|---|---|---|
| Experimental administration group | Experimental | Irinotecan hydrochloride liposome injection: 70mg/m2, intravenous infusion CISPLATIN: 60mg/m2, intravenous infusion or carboplatin: AUC=5, intravenous infusion Receives: Drug: Irinotecan hydrochloride liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Secondary outcomes (4)
Progression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Duration of Response
Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death
Measured: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Measured: The maximum time from receiving treatment to dying for any reason is 4 years.
Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Measured: From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start15 Mar 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 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.
- More trials run by Tang-Du HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haichuan Su, PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467786
- Sponsor's protocol ID
- 202402-30
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06467786
- Acronym / sponsor ID
- 202402-30
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, Platinum sensitive, Irinotecan liposomes, Second-Line Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 21 Jun 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 is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.
Detailed description
Based on literature research and the birth of independently developed irinotecan liposomes by Shiyao, we plan to conduct a therapeutic study on the combination of irinotecan liposomes and cisplatin/carboplatin for platinum sensitive recurrent small cell lung cancer. The aim is to explore the efficacy and safety of the combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line treatment of small cell lung cancer patients who have progressed after 6 months using platinum based regimens, providing better clinical evidence for use.
The research unit is the Second Affiliated Hospital of Air Force Military Medical University. The study includes screening period (within 28 days), treatment period, and follow-up period (safety follow-up and PFS follow-up). The subjects signed an informed consent form and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety, tolerance, and efficacy. The same subject only received one dosing plan during the study period. After the treatment period ends, enter the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental administration group | Experimental | Drug: Irinotecan hydrochloride liposome injectionIrinotecan hydrochloride liposome injection: 70mg/m2, intravenous infusion CISPLATIN: 60mg/m2, intravenous infusion or carboplatin: AUC=5, intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF).
- Age ≥ 18 years old;
- Patients with extensive stage small cell lung cancer diagnosed by pathology or histology;
- According to RECIST 1.1 standard, patients have at least one measurable target lesion; For lesions that have undergone radiation therapy in the past, they can only be included as measurable lesions if there is clear disease progression after radiation therapy;
- Progression confirmed by imaging examination after 6 months of first-line radiotherapy and chemotherapy containing platinum drugs or platinum regimen radiotherapy and chemotherapy ± immunotherapy;
Key exclusion criteria (16 listed)
- Patients with large cell neuroendocrine tumors and mixed small cell carcinoma;
- Patients with active brain metastasis or central nervous system invasion confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥ 10mg);
- There is an hypersensitivity reaction to any investigational drug or its components;
- Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
- Heart function and disease meet one of the following conditions:
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 combined with platinum | Drug | Experimental administration group |
Primary outcome
Intracranial Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
4 secondary outcomes
Progression-free survival
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Duration of Response
Time frame: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years
Overall Survival
Time frame: The maximum time from receiving treatment to dying for any reason is 4 years.
Safety/Adverse event
Time frame: From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy
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 21 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Haichuan Su, PhD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan hydrochloride liposome injection in people with Small Cell Lung Cancer, run by Tang-Du Hospital 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 10 inclusion and 16 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 21 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Haichuan Su, PhD (18629190366, such@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Objective response rate (time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 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 21 Jun 2024.