Small Cell Lung CarcinomaPhase 1/2NCT04996771
Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in the Treatment of Small Cell Lung Cancer
A Phase 1/2 study testing Surufatinib,Etoposide,Cisplatin,Toripalimab and Surufatinib,Etoposide,Cisplatin in people with Small Cell Lung Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Surufatinib,Etoposide,Cisplatin,Toripalimab and Surufatinib,Etoposide,Cisplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2021to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: ≥18 years old;
- Expected survival period ≥ 3 months;
- Adavanced small cell lung cancer confirmed by histology ;
- According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
- ECOG PS: 0-1;
Show all 9Show fewer
- Laboratory test indicators must meet the following requirements: Hematology: white blood cells ≥4.0×10^9/L, neutrophils ≥2.0×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90g/L. Liver function: serum bilirubin is lower than 1.5 times the maximum normal value; for patients without liver metastasis: ALT and AST are lower than 2.5 times the maximum normal value; for patients with liver metastasis: ALT and AST are lower than 5 times the maximum normal value ; Measured or calculated creatinine clearance: According to the Cockcroft-Gault formula (using actual body weight), patients receiving cisplatin treatment>60mL/min, and patients receiving carboplatin treatment>45mL/min;
- Good compliance and follow-up;
- The urine or serum pregnancy test results of premenopausal women were negative.
Who cannot join
- Patients with symptomatic brain metastases;
- People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
- Urine routine test showed urine protein ≥+++ and confirmed 24-hour urine protein quantification>3.0g;
- 5.Cardiovascular disease history: congestive heart failure> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment (Allows to take beta blockers or digoxin); 6.Active severe clinical infections (>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive). Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative; 7.Patients with bleeding tendency or coagulation disorders, (14 days before randomization must meet: INR is within the normal range without the use of anticoagulants); 8.In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment); 9.Those who have received live vaccination within 4 weeks before the start of treatment; 10.Those who had suffered from tumors other than small cell lung cancer within 5 years before being enrolled in this study. Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor; 11.Severe unhealed wounds, ulcers or fractures; 12.Patients who are pregnant or breastfeeding ; 13.Any unstable conditions may endanger the safety of patients and affect their compliance with research; 14.Researchers think it is inappropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Wenfeng Fang, MD., +86-15322302066, fangwf@sysucc.org.cn
About this study
Official title: A Phase Ⅰb/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer
To evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Surufatinib,Etoposide,Cisplatin,Toripalimab, Surufatinib,Etoposide,Cisplatin
- 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.
Surufatinib,Etoposide,Cisplatin,ToripalimabDrug
In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total.
At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w＋Toripalimab 240mg,d1,q3w was taken orally until the disease progressed.
Surufatinib,Etoposide,CisplatinDrug
In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total.
At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w was taken orally until the disease progressed.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib Combined With Toripalimab and Chemotherapy | Experimental | Not described Receives: Drug: Surufatinib,Etoposide,Cisplatin,Toripalimab |
| Surufatinib Combined With Chemotherapy | Experimental | Not described Receives: Drug: Surufatinib,Etoposide,Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival(PFS)
Measured: up to 24 months
Secondary outcomes (3)
Objective response rate(ORR)
Measured: up to 24 months
Overall Survival(OS)
Measured: up to 24 months
Disease control rate(DCR)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start9 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996771
- Sponsor's protocol ID
- HMPL-012-SPRING-L103
- Status last verified
- Nov 2022
- First submitted
- 5 Aug 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2.
PubMed 39327433
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04996771
- Acronym / sponsor ID
- HMPL-012-SPRING-L103
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Aug 2021 (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 evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surufatinib Combined With Toripalimab and Chemotherapy | Experimental | Drug: Surufatinib,Etoposide,Cisplatin,Toripalimab |
| Surufatinib Combined With Chemotherapy | Experimental | Drug: Surufatinib,Etoposide,Cisplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: ≥18 years old;
- Expected survival period ≥ 3 months;
- Adavanced small cell lung cancer confirmed by histology ;
- According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
Key exclusion criteria (4 listed)
- Patients with symptomatic brain metastases;
- People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
- Urine routine test showed urine protein ≥+++ and confirmed 24-hour urine protein quantification>3.0g;
- 5.Cardiovascular disease history: congestive heart failure> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment (Allows to take beta blockers or digoxin); 6.Active severe clinical infections (>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive). Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative; 7.Patients with bleeding tendency or coagulation disorders, (14 days before randomization must meet: INR is within the normal range without the use of anticoagulants); 8.In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment); 9.Those who have received live vaccination within 4 weeks before the start of treatment; 10.Those who had suffered from tumors other than small cell lung cancer within 5 years before being enrolled in this study. Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor; 11.Severe unhealed wounds, ulcers or fractures; 12.Patients who are pregnant or breastfeeding ; 13.Any unstable conditions may endanger the safety of patients and affect their compliance with research; 14.Researchers think it is inappropriate to participate in this trial.
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 |
|---|---|---|
| Surufatinib,Etoposide,Cisplatin,ToripalimabIn dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w＋Toripalimab 240mg,d1,q3w was taken orally until the disease progressed. | Drug | Surufatinib Combined With Toripalimab and Chemotherapy |
| Surufatinib,Etoposide,CisplatinIn dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w was taken orally until the disease progressed. | Drug | Surufatinib Combined With Chemotherapy |
Primary outcome
Progress Free Survival(PFS)
Time frame: up to 24 months
3 secondary outcomes
Objective response rate(ORR)
Time frame: up to 24 months
Overall Survival(OS)
Time frame: up to 24 months
Disease control rate(DCR)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 39327433Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2.
- Individual participant dataSharing planned: Undecided
Related trials for Small Cell Lung Carcinoma
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Surufatinib,Etoposide,Cisplatin,Toripalimab and Surufatinib,Etoposide,Cisplatin in people with Small Cell Lung Carcinoma, run by Sun Yat-sen 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 9 inclusion and 4 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 14 Nov 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wenfeng Fang, MD. (+86-15322302066, fangwf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival(PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996771, which also lists 1 linked publication.
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 14 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.