Small Cell Lung CancerPhase 2NCT05595889
Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer
A Phase 2 study testing Surufatinib and Irinotecan in people with Small Cell Lung Cancer and Angiogenesis, run by Fujian Cancer Hospital.
Trial summary
To evaluate the clinical efficacy and safety of surufatinib combined with irinotecan in the second line treatment of small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Cancer, Angiogenesis, Chemotherapy Effect
- What is being tested?
- Surufatinib and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Sep 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years; Volunteer to participate in the trial and sign informed consent;
- Small cell lung cancer diagnosed by histopathology;
- Previous failure to receive first-line standard treatment was defined as intolerable toxic and side effects, disease progression during treatment, or recurrence after treatment; Intolerability was defined as grade IV (thrombocytopenia grade III and above) for hematologic toxicity and grade III or above for nonhematologic toxicity. Note: Each line of drug refers to medication for at least 1 cycle regardless of single drug or multi-drug combination;
- ECOG score: 0-1;
- At least one lesion detectable by CT, according to RECIST 1.1;
- Expected survival ≥12 weeks;
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- At least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);
- The functions of major organs and bone marrow are basically normal:
- Blood routine: white blood cell ≥ 4.0 x 109/L, neutrophil ≥ 1.5 x 109/L, platelet ≥ 100 x 109/L, hemoglobin ≥ 90 g/L; A) International normalized ratio (INR) ≤1.5× upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5×ULN; B) Liver function: total bilirubin ≤ 1.5 x ULN; In the absence of liver metastasis, ALT/AST /ALP ≤ 2.5 x ULN; ALT/AST /ALP ≤ 5 x ULN in patients with liver metastasis; C) Renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance (CCr) 60 mL/min (see Appendix 6); D) Normal cardiac function, left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.
- Brain metastases must have been asymptomatic or treated and stabilized after discontinuation of steroids and anticonvulsants for at least 1 month prior to study treatment;
- Patients of childbearing age (including female and female partners of male patients) must take effective birth control measures;
- Good compliance is expected, and the efficacy and adverse reactions can be followed up according to the protocol requirements.
Who cannot join
- Small cell lung cancer with other pathological types of tumors;
- Previously received anti-angiogenic drugs, including bevacizumab, sovanitinib, sunitinib, sorafenib, anlotinib, apatinib, etc.
- Receive the following treatments within the first 4 weeks of treatment, including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs;
- Pregnant or lactating women;
- With pleural effusion or ascites, respiratory syndrome (≥CTC AE grade 2 dyspnea);
- Symptomatic brain or meningeal metastases (except those who have undergone local radiotherapy or surgery for brain metastases for more than 6 months and have stable disease control);
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- Severe infection (e.g., intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks prior to treatment, or unexplained fever > 38.5 ° C during screening/initial administration;
- Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- The urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantity >1.0g;
- Obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melanism, blood in stool), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event in the previous 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required;
- Active heart disease, including myocardial infarction and severe/unstable angina, developed 6 months before treatment. Echocardiography showed left ventricular ejection fraction < 50% and poor arrhythmia control (including QTcF interval, > 450 ms in men and > 470 ms in women).
- The patient had had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the previous 3 years or at the same time.
- Known allergy to the study drug or any of its excipients;
- Active or uncontrolled severe infections;
- Known human immunodeficiency virus (HIV) infection;
- A known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positivity (>1×104 copies /mL or >2000 IU/ mL);
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, liver cirrhosis];
- Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to suspect the patient has not suitable for the use of study drugs of a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or to make patients in high-risk situations;
- Other conditions deemed inappropriate for inclusion by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study
To evaluate the clinical efficacy and safety of surufatinib combined with irinotecan in the second line treatment of small cell lung cancer.
Read the detailed description
According to the inclusion and exclusion criteria, 40 patients with small cell lung cancer who failed to receive standard first-line therapy were selected to evaluate the efficacy and safety of surufatinib combined with irinotecan in the second-line treatment of small cell lung cancer.
- Conditions
- Small Cell Lung Cancer, Angiogenesis, Chemotherapy Effect
- Being tested
- Surufatinib, 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.
SurufatinibDrug
Also called SULANDA
250 mg/day p.o. QD
IrinotecanDrug
Participants will receive irinotecan，100 mg/m2，Intravenous drip, day 1 and day 8 of every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib combined with irinotecan | Experimental | Surufatinib combined with irinotecan as a second-line treatment for small cell lung cancer Receives: Drug: Surufatinib; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Objective remission rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including cases of complete remission and partial remission.
Measured: up to 12 months
Disease control rate
The percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in whom response could be evaluated.
Measured: up to 12 months
Overall survival（OS）
OS was defined as the time from the date of randomization to the date of death due to any cause. For subjects who were alive or lost to follow-up by the data analysis cut-off date, survival was censored at the subject's last known survival time.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (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 Fujian Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhiyong He, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595889
- Sponsor's protocol ID
- HMPL-012-E1-SCLC-001
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT05595889
- Acronym / sponsor ID
- HMPL-012-E1-SCLC-001
- Conditions
- Small Cell Lung Cancer, Angiogenesis, Chemotherapy Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Oct 2022 (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.
To evaluate the clinical efficacy and safety of surufatinib combined with irinotecan in the second line treatment of small cell lung cancer.
Detailed description
According to the inclusion and exclusion criteria, 40 patients with small cell lung cancer who failed to receive standard first-line therapy were selected to evaluate the efficacy and safety of surufatinib combined with irinotecan in the second-line treatment of small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib combined with irinotecan | Experimental | Drug: Surufatinib, Drug: IrinotecanSurufatinib combined with irinotecan as a second-line treatment for small cell lung cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years; Volunteer to participate in the trial and sign informed consent;
- Small cell lung cancer diagnosed by histopathology;
- Previous failure to receive first-line standard treatment was defined as intolerable toxic and side effects, disease progression during treatment, or recurrence after treatment; Intolerability was defined as grade IV (thrombocytopenia grade III and above) for hematologic toxicity and grade III or above for nonhematologic toxicity. Note: Each line of drug refers to medication for at least 1 cycle regardless of single drug or multi-drug combination;
- ECOG score: 0-1;
- At least one lesion detectable by CT, according to RECIST 1.1;
Key exclusion criteria (19 listed)
- Small cell lung cancer with other pathological types of tumors;
- Previously received anti-angiogenic drugs, including bevacizumab, sovanitinib, sunitinib, sorafenib, anlotinib, apatinib, etc.
- Receive the following treatments within the first 4 weeks of treatment, including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs;
- Pregnant or lactating women;
- With pleural effusion or ascites, respiratory syndrome (≥CTC AE grade 2 dyspnea);
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 |
|---|---|---|
| SurufatinibAlso: SULANDA250 mg/day p.o. QD | Drug | Surufatinib combined with irinotecan |
| IrinotecanParticipants will receive irinotecan，100 mg/m2，Intravenous drip, day 1 and day 8 of every 3 weeks | Drug | Surufatinib combined with irinotecan |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
3 secondary outcomes
Objective remission rate (ORR)
Time frame: up to 12 months
Disease control rate
Time frame: up to 12 months
Overall survival（OS）
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- 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.
Zhiyong He study chair
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib and Irinotecan in people with Small Cell Lung Cancer and Angiogenesis, run by Fujian Cancer Hospital.
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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong He (13805086391, heyong1015@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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 29 Nov 2022.