Small Cell Lung Cancer RecurrentNCT06258642
Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC
A study testing Irinotecan Liposome and Anlotinib in people with Small Cell Lung Cancer Recurrent, run by Fudan University at 1 site in China.
Trial summary
This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Recurrent
- What is being tested?
- Irinotecan Liposome and Anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 31 Dec 2026
- 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
- 1) Aged ≥18 and ≤75 years old;
- 2) Histologically or cytologically confirmed small cell lung cancer;
- 3) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
- 4) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
- 5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- 6) Expected survival of more than 3 months;
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- 7) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);
- 8) Adequate major organ function, patients should meet the following criteria:
- ① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109/L，platelet (PLT)≥100×109/L, hemoglobin (Hb)≥90g/L, white blood cell (WBC)≥3.0×109/L；
- ② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN)；ALT and AST≤2.5×ULN，liver metastasis：≤5×ULN；
- ③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min;
- ④ Coagulation function：Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN；
- ⑤ urine routines show urine protein < 2+(when urine protein >2+, urine protein quantity< 1.0 g during 24 hours before 7 days);
- 9) Patients fully understood and volunteered to participate in the study.
Who cannot join
- 1) Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma;
- 2) Patients with asymptomatic central nervous system (CNS) metastases prior to enrollment or those who have CNS disease requiring increase in the dose of steroid. (Patients with controlled CNS metastasis can participate in the trial);
- 3) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks prior to the first dose of this study, and those judged by the clinicians to be unsuitable for the study;
- 4) Diagnosed with any other cancer within the past 5 years (except for cured basal cell carcinoma and in situ cancer);
- 5) Patients who have received prior irinotecan/ liposomal irinotecan and anti-angiogenic drugs such as anlotinib and bevacizumab , etc.
- 6) Concomitant use of strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week of the first dose of the study drug;
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- 7) Patients who have received other anti-tumor treatments(including radiotherapy, chemotherapy, immunotherapy, etc.) within 4 weeks before the first dose;
- 8) Combined with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe ventricular arrhythmia , etc.
- 9) Severe pulmonary disease within 6 months prior to enrolment, such as interstitial pneumonia, pulmonary fibrosis, radiation induced pneumonitis requiring steroid therapy, and other moderate and severe lung diseases which affect lung function;
- 10) Arterial/venous thrombosis within 6 months prior to enrollment, e.g. cerebrovascular accident (include temporary ischemic attack), deep venous thrombosis, pulmonary embolism.
- 11) Symptoms or propensity to bleed within 3 months prior to screening (include gastrointestinal hemorrhage, ulcerative gastric bleeding, fecal occult blood 2+ or above, vasculitis);
- 12) Patients had undergone major surgical procedure(except for diagnostic surgery) within 4 weeks before dosing or was scheduled to receive major procedure during the study;
- 13) unhealed wounds, ulcers or fractures;
- 14) Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage;
- 15) Active and uncontrolled bacterial, viral, fungal infection requiring systemic treatment;
- 16) Active hepatitis B/C, or HIV infection;
- 17) Known intolerance or allergy to therapeutic drugs and their excipients;
- 18) Clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1;
- 19) Pregnant or breast feeding;
- 20) Patient is not suitable for the study in the investigator's opinion.
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 Fudan University
Shanghai, Shanghai Municipality, 200032
Jialei Wang, 02164175590 ext. 88900, luwangjialei@hotmail.com
About this study
Official title: Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer
This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.
Read the detailed description
Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, on Days 1 of every 14-day cycle and anlotinib (12 mg/day) for 2 consecutive weeks and then discontinued for 1 week. The treatment is continued until disease progression or intolerable toxicity.
- Conditions
- Small Cell Lung Cancer Recurrent
- Being tested
- Irinotecan Liposome, Anlotinib
- Keywords
- Small Cell Lung Cancer, liposomal irinotecan
- 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 LiposomeDrug
Also called Irinotecan liposome injection
70 mg/m^2 , d1, Q2W, iv
AnlotinibDrug
Also called Anlotinib hydrochloride
12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan Liposome and anlotinib | Experimental | The treatment is continued until disease progression or intolerable toxicity Receives: Drug: Irinotecan Liposome; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
To evaluate anti-tumor efficacy
Measured: From date of first dose until the date of first documented progression, assessed up to 24 months
Secondary outcomes (5)
Disease control rate (DCR)
To evaluate anti-tumor efficacy
Measured: From date of first dose until the date of first documented progression, assessed up to 24 months
Duration of Response(DoR)
To evaluate anti-tumor efficacy
Measured: From date of first dose until the date of first documented progression, assessed up to 24 months
Progression-Free Survival (PFS)
To evaluate anti-tumor efficacy
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
To evaluate anti-tumor efficacy
Measured: From date of first dose until the date of death from any cause , assessed up to 24 months
Incidence and severity of adverse events
To evaluate the safety
Measured: date of the first dose to 28 days after permanent treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start17 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (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 Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
- Investigators
- Jialei Wang, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258642
- Sponsor's protocol ID
- CSPC-DEY-SCLC-K01
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2024
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06258642
- Acronym / sponsor ID
- CSPC-DEY-SCLC-K01
- Conditions
- Small Cell Lung Cancer Recurrent
- Keywords
- Small Cell Lung Cancer, liposomal irinotecan
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 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 single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.
Detailed description
Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, on Days 1 of every 14-day cycle and anlotinib (12 mg/day) for 2 consecutive weeks and then discontinued for 1 week. The treatment is continued until disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Liposome and anlotinib | Experimental | Drug: Irinotecan Liposome, Drug: AnlotinibThe treatment is continued until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1) Aged ≥18 and ≤75 years old;
- 2) Histologically or cytologically confirmed small cell lung cancer;
- 3) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
- 4) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
- 5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Key exclusion criteria (20 listed)
- 1) Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma;
- 2) Patients with asymptomatic central nervous system (CNS) metastases prior to enrollment or those who have CNS disease requiring increase in the dose of steroid. (Patients with controlled CNS metastasis can participate in the trial);
- 3) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks prior to the first dose of this study, and those judged by the clinicians to be unsuitable for the study;
- 4) Diagnosed with any other cancer within the past 5 years (except for cured basal cell carcinoma and in situ cancer);
- 5) Patients who have received prior irinotecan/ liposomal irinotecan and anti-angiogenic drugs such as anlotinib and bevacizumab , etc.
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 LiposomeAlso: Irinotecan liposome injection70 mg/m^2 , d1, Q2W, iv | Drug | Irinotecan Liposome and anlotinib |
| AnlotinibAlso: Anlotinib hydrochloride12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week. | Drug | Irinotecan Liposome and anlotinib |
Primary outcome
Objective response rate（ORR）
Time frame: From date of first dose until the date of first documented progression, assessed up to 24 months
To evaluate anti-tumor efficacy
5 secondary outcomes
Disease control rate (DCR)
Time frame: From date of first dose until the date of first documented progression, assessed up to 24 months
Duration of Response(DoR)
Time frame: From date of first dose until the date of first documented progression, assessed up to 24 months
Progression-Free Survival (PFS)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Time frame: From date of first dose until the date of death from any cause , assessed up to 24 months
Incidence and severity of adverse events
Time frame: date of the first dose to 28 days after permanent treatment termination
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 20 Aug 2025.
- 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.
Jialei Wang, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irinotecan Liposome and Anlotinib in people with Small Cell Lung Cancer Recurrent, run by Fudan University 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 14 inclusion and 20 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 20 Aug 2025. 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.
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 Jialei Wang, Doctor (021-64175590 ext. 88900, luwangjialei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: From date of first dose until the date of first documented progression, assessed up to 24 months). 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 20 Aug 2025.