Small Cell Lung CancerNCT06462105
Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer
A study testing Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection in people with Small Cell Lung Cancer, run by Zhou Chengzhi.
Trial summary
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2024to 30 Jun 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)；
- Age ≥18 years；
- Patients with pathologically or histologically confirmed extensive stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging system)；
- The patient had not previously received any form of antitumor therapy；
- According to RECIST1.1 criteria, the patient had at least one measurable target lesion；
- Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2；
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- The expected survival time is ≥3 months；
- Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥100×10^9/L, and hemoglobin ≥90 g/L (no blood transfusion, blood products, correction with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 14 days prior to laboratory examination)；
- Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)；
- Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial period and for 6 months after the last dose of the test drug.
Who cannot join
- Patients with large cell neuroendocrine tumor and mixed small cell carcinoma；
- Patients with active brain metastases or central nervous system invasion； confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥10mg)；
- Allergic reaction to any investigational drug or its ingredients；
- The patient has previously received other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, CTLA4, etc；
- Serious, uncontrolled comorbidities that could affect the study results, including but not limited to serious infections, diabetes, or cardiovascular and cerebrovascular disease, were identified；
- Imaging confirmed intestinal obstruction；
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- It has uncontrollable ascites, abdominal infection and pyloric obstruction；
- Cardiac function and disease: a history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities in the 6 months prior to recruitment；
- Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA)；
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
- Pregnant and lactating women and patients of childbearing age who do not want to use contraception;
- The investigators determined that patients were not suitable to participate in this study.
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: Randomized Phase II Clinical Study of Liposomal Irinotecan or Etoposide Combined With Carboplatin and Serplulimab as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
Read the detailed description
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
Trial design: This is a multicenter, open-label, non-comparative, randomized Phase II clinical study. Sixty patients with extensive stage small cell lung cancer were expected to be enrolled and randomly assigned 1:1 to either liposomal irinotecan + carboplatin + serplulimab or etoposide + carboplatin + serplulimab for treatment. The study included a screening period (within 28 days), a treatment period (4 cycles planned), and a follow-up period (safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed relevant examinations specified in the protocol during treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study. After the treatment period, the follow-up period was entered.
Treatment regimen: Cohort 1: Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Cohort 2: Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable.
Endpoint: Primary endpoint: Progression-free survival (PFS). Secondary endpoints: Objective response rate (ORR), disease control rate (DCR), overall survival (OS), and outcome in brain metastases (PFS).
Safety endpoints: Incidence and severity of hematologic and nonhematologic adverse events (NCI-CTCAE5.0).
Follow-up: After the end of the treatment period, the follow-up period was entered, which was once every 2 months in the first year and once every 3-4 months in the second to third year.
Statistical analysis: IBM SPSS software (version 25.0 or above) was used for statistical analysis in this study. The measurement data were described statistically with mean, median, standard deviation, maximum and minimum values. Count data or grade data use case number, percentage representation.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection
- 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 Injection；Carboplatin Injection；Serplulimab InjectionDrug
Also called Etoposide Injection；Carboplatin Injection；Serplulimab Injection
Cohort 1: Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable.
Cohort 2: Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal irinotecan + Carboplatin + Serplulimab | Experimental | Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Receives: Drug: Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection |
| Etoposide + Carboplatin + Serplulimab | Experimental | Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Receives: Drug: Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（PFS）
The PFS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated
Measured: The time between the subject's signing of the informed consent and the onset of tumor progression (according to RECIST v1.1 criteria) or death.
Secondary outcomes (4)
Objective response rate（ORR）
ORR use cases, percentage representation
Measured: Percentage of tumor volume reduction to complete response (CR) and partial response (PR) (according to RECIST v1.1 criteria).
Disease control rate（DCR）
DCR use cases, percentage representation
Measured: Best tumor response based on RECIST1.1 criteria, the proportion of CR, PR and SD.
Overall survival（OS）
The OS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated
Measured: The time between the subject signing the informed consent form and the patient's death due to various causes.
Incidence and severity of hematological and non-hematological adverse events
Safety: The number and frequency of adverse events, serious adverse events, and treatment-related adverse events (NCI CTCAE v5.0) individually and collectively were listed and the incidence rate was calculated.
Measured: The time between the subject signing the informed consent and the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start5 Jul 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Hunan Cancer Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Foshan, Youjiang Medical College for Nationalities
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462105
- Sponsor's protocol ID
- ES-2024-072-02
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Clinical Study of Liposomal Irinotecan or Etoposide Combined With Carboplatin and Serplulimab as First-line Treatment for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06462105
- Acronym / sponsor ID
- ES-2024-072-02
- Conditions
- Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Hunan Cancer Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Foshan, Youjiang Medical College for Nationalities
- Study start
- 5 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 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.
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
Detailed description
Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
Trial design: This is a multicenter, open-label, non-comparative, randomized Phase II clinical study. Sixty patients with extensive stage small cell lung cancer were expected to be enrolled and randomly assigned 1:1 to either liposomal irinotecan + carboplatin + serplulimab or etoposide + carboplatin + serplulimab for treatment. The study included a screening period (within 28 days), a treatment period (4 cycles planned), and a follow-up period (safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed relevant examinations specified in the protocol during treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study. After the treatment period, the follow-up period was entered.
Treatment regimen: Cohort 1: Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Cohort 2: Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable.
Endpoint: Primary endpoint: Progression-free survival (PFS). Secondary endpoints: Objective response rate (ORR), disease control rate (DCR), overall survival (OS), and outcome in brain metastases (PFS).
Safety endpoints: Incidence and severity of hematologic and nonhematologic adverse events (NCI-CTCAE5.0).
Follow-up: After the end of the treatment period, the follow-up period was entered, which was once every 2 months in the first year and once every 3-4 months in the second to third year.
Statistical analysis: IBM SPSS software (version 25.0 or above) was used for statistical analysis in this study. The measurement data were described statistically with mean, median, standard deviation, maximum and minimum values. Count data or grade data use case number, percentage representation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal irinotecan + Carboplatin + Serplulimab | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab InjectionLiposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. |
| Etoposide + Carboplatin + Serplulimab | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab InjectionEtoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)；
- Age ≥18 years；
- Patients with pathologically or histologically confirmed extensive stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging system)；
- The patient had not previously received any form of antitumor therapy；
- According to RECIST1.1 criteria, the patient had at least one measurable target lesion；
Key exclusion criteria (13 listed)
- Patients with large cell neuroendocrine tumor and mixed small cell carcinoma；
- Patients with active brain metastases or central nervous system invasion； confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥10mg)；
- Allergic reaction to any investigational drug or its ingredients；
- The patient has previously received other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, CTLA4, etc；
- Serious, uncontrolled comorbidities that could affect the study results, including but not limited to serious infections, diabetes, or cardiovascular and cerebrovascular disease, were identified；
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 Injection；Carboplatin Injection；Serplulimab InjectionAlso: Etoposide Injection；Carboplatin Injection；Serplulimab InjectionCohort 1: Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Cohort 2: Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. | Drug | Etoposide + Carboplatin + Serplulimab, Liposomal irinotecan + Carboplatin + Serplulimab |
Primary outcome
Progression-free survival（PFS）
Time frame: The time between the subject's signing of the informed consent and the onset of tumor progression (according to RECIST v1.1 criteria) or death.
The PFS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated
4 secondary outcomes
Objective response rate（ORR）
Time frame: Percentage of tumor volume reduction to complete response (CR) and partial response (PR) (according to RECIST v1.1 criteria).
Disease control rate（DCR）
Time frame: Best tumor response based on RECIST1.1 criteria, the proportion of CR, PR and SD.
Overall survival（OS）
Time frame: The time between the subject signing the informed consent form and the patient's death due to various causes.
Incidence and severity of hematological and non-hematological adverse events
Time frame: The time between the subject signing the informed consent and the end of treatment
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 28 Jun 2024.
- Individual participant dataSharing planned: Yes
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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 study testing Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection in people with Small Cell Lung Cancer, run by Zhou Chengzhi.
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 13 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 28 Jun 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.
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 Chenzhi Zhou, Doctor of philosophy (020-83062830, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS） (time frame: The time between the subject's signing of the informed consent and the onset of tumor progression (according to RECIST v1.1 criteria) or death.). 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 28 Jun 2024.