Extensive-Stage Small Cell Lung CancerPhase 2NCT05509699
Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Surufatinib and Anti-PD-1/L1 in people with Extensive-Stage Small Cell Lung Cancer, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Surufatinib and Anti-PD-1/L1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to 31 Jul 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who sufficiently understand this study and is willing to sign the ICF;
- Aged from 18 to 75 years (inclusive);
- Patients with histologically or cytologically confirmed ES-SCLC ;
- Patients who did not have PD (assessed as per the RECIST v1.1) after prior first-line platinum-based chemotherapy plus an anti-PD-1/L1;
- Patients with measurable lesions as defined in the RECIST v1.1 ;
- Life expectancy ≥ 12 weeks;
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- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1;
- Adequate organ function:
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Male or female patients of childbearing potential should be willing to use effective contraceptive methods during the study and within 90 days after last dose of the study drug.
Who cannot join
- Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular endothelial growth factor receptor (VEGFR) agents;
- Use of systematic anti-tumor therapies other than first-line platinum-based chemotherapy in combination with anti-PD-1/L1 within 4 weeks prior to the first dose;
- Presence of central nervous system (CNS) metastasis and/or cancerous meningitis (metastases to meninges);
- Toxicities associated with previous anti-tumor treatment that has not been resolved to CTCAE Grade ≤ 1, except for alopecia and CTCAE Grade ≤ 2 peripheral neurotoxicity;
- Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
- Patients with active autoimmune disorder or immunodeficiency or history of autoimmune disorder or immunodeficiency;
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- Patients with evidence or history of obvious bleeding tendency within 2 months prior to the first dose;
- Clinically significant cardiovascular disorders;
- Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia;
- Patients who are unable to take oral medications, or with previous surgical history or severe gastrointestinal;
- Pregnant (with a positive pregnancy test) or lactating women within 5 years before screening.
- Patients with a history of malignant tumors excluding small cell lung cancer (SCLC) within 5 years before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multi-Center Phase II Study of Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Patients With Extensive-Stage Small Cell Lung Cancer
This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC.
Read the detailed description
This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized, controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after prior platinum-based chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy and safety. Approximately 40 patients are planned to be enrolled in the randomized and controlled Phase IIb study with 20 patients per group.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Surufatinib, Anti-PD-1/L1
- 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
The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.
Anti-PD-1/L1Drug
Also called Immune checkpoint inhibitor
Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib in combination with anti-PD-1/L1 therapy | Experimental | Surufatinib 250 mg orally once plus anti-PD-1/L1, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy. Receives: Drug: Surufatinib; Drug: Anti-PD-1/L1 |
| Anti-PD-1/L1 monotherapy | Experimental | Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy Receives: Drug: Anti-PD-1/L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival(PFS) assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Measured: About 18 months
Secondary outcomes (4)
Overall survival
Overall survival (OS)
Measured: About 18 months
Objective response rate
Objective response rate (ORR) assessed per RECIST v1.1
Measured: About 18 months
Disease control rate
Disease control rate (DCR) assessed per RECIST v1.1
Measured: About 18 months
Duration of response
Duration of response (DoR) assessed per RECIST v1.1
Measured: About 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start27 Sep 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two parts, i.e., a single-arm Phase IIa study and a randomized (1:1), controlled Phase IIb study. Phase IIa: It is planned that 20 patients will be enrolled to receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy . Phase IIb: It is planned that 40 patients will be enrolled to receive the following treatments: Group A: Patients will receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy. Group B: Patients will receive treatment with anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Hu, Postdoctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509699
- Sponsor's protocol ID
- 2022-012-00CH1
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2022
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Phase II Study of Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05509699
- Acronym / sponsor ID
- 2022-012-00CH1
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Aug 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.
This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC.
Detailed description
This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized, controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after prior platinum-based chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy and safety. Approximately 40 patients are planned to be enrolled in the randomized and controlled Phase IIb study with 20 patients per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two parts, i.e., a single-arm Phase IIa study and a randomized (1:1), controlled Phase IIb study. Phase IIa: It is planned that 20 patients will be enrolled to receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy . Phase IIb: It is planned that 40 patients will be enrolled to receive the following treatments: Group A: Patients will receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy. Group B: Patients will receive treatment with anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy.
| Arm | Type | Receives |
|---|---|---|
| Surufatinib in combination with anti-PD-1/L1 therapy | Experimental | Drug: Surufatinib, Drug: Anti-PD-1/L1Surufatinib 250 mg orally once plus anti-PD-1/L1, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy. |
| Anti-PD-1/L1 monotherapy | Experimental | Drug: Anti-PD-1/L1Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who sufficiently understand this study and is willing to sign the ICF;
- Aged from 18 to 75 years (inclusive);
- Patients with histologically or cytologically confirmed ES-SCLC ;
- Patients who did not have PD (assessed as per the RECIST v1.1) after prior first-line platinum-based chemotherapy plus an anti-PD-1/L1;
- Patients with measurable lesions as defined in the RECIST v1.1 ;
Key exclusion criteria (12 listed)
- Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular endothelial growth factor receptor (VEGFR) agents;
- Use of systematic anti-tumor therapies other than first-line platinum-based chemotherapy in combination with anti-PD-1/L1 within 4 weeks prior to the first dose;
- Presence of central nervous system (CNS) metastasis and/or cancerous meningitis (metastases to meninges);
- Toxicities associated with previous anti-tumor treatment that has not been resolved to CTCAE Grade ≤ 1, except for alopecia and CTCAE Grade ≤ 2 peripheral neurotoxicity;
- Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
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 |
|---|---|---|
| SurufatinibThe recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration. | Drug | Surufatinib in combination with anti-PD-1/L1 therapy |
| Anti-PD-1/L1Also: Immune checkpoint inhibitorAnti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy. | Drug | Anti-PD-1/L1 monotherapy, Surufatinib in combination with anti-PD-1/L1 therapy |
Primary outcome
Progression-free survival
Time frame: About 18 months
Progression-free survival(PFS) assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
4 secondary outcomes
Overall survival
Time frame: About 18 months
Objective response rate
Time frame: About 18 months
Disease control rate
Time frame: About 18 months
Duration of response
Time frame: About 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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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.
Yi Hu, Postdoctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib and Anti-PD-1/L1 in people with Extensive-Stage Small Cell Lung Cancer, run by Hutchison Medipharma Limited 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 12 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: finished, as of the sponsor's last update on 29 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: About 18 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 Aug 2025.