ClinicalTrials.gg
CompletedNCT05509699Updated Aug 29, 2025

Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

A Phase 2 interventional study of Surufatinib and Anti-PD-1/L1 in Extensive-Stage Small Cell Lung Cancer, sponsored by Hutchison Medipharma Limited. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Hutchison Medipharma Limited (part of HUTCHMED) · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 233 studies testing Immune checkpoint inhibitors in Small Cell Lung Carcinoma — 89 open to participants now, 120 under way, 17 of them phase 3. A drug class: Immune checkpoint inhibitors · Small Cell Lung Carcinoma.

Enrollment
196th of 233
21 · median 50
Started
2022
with 16 others
Phase 2
140 of 233
59 open now
Registered
136th of 233
by date

Among the 233 studies testing Immune checkpoint inhibitors in Small Cell Lung Carcinoma, this one is the 196th largest by enrollment, is one of 17 that started in 2022, is one of 140 in phase 2, and was the 136th registered.

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.

Browse Small Cell Lung Carcinoma studies →

Open to participants now

89 of the 233 studies testing Immune checkpoint inhibitors in Small Cell Lung Carcinoma are open now, in 12 countries. Recruiting first, the newest first:

84 more — sign in →

By country, each count listing its studies:

All 89 open studies →

About Immune checkpoint inhibitors

A class of medicines: which ones, and the studies of each, are on its page →

Who these studies take

Of the 265 Small Cell Lung Carcinoma studies recruiting now, 175 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 233 studies testing Immune checkpoint inhibitors in Small Cell Lung Carcinoma, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Extensive-Stage Small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who sufficiently understand this study and is willing to sign the ICF;
  2. Aged from 18 to 75 years (inclusive);
  3. Patients with or cytologically confirmed ES-SCLC ;
  4. Patients who did not have PD (assessed as per the v1.1) after prior platinum-based chemotherapy plus an /L1;
  5. Patients with as defined in the RECIST v1.1 ;
  6. ≥ 12 weeks;
  7. (ECOG) Performance Status score of 0 to 1;
  8. Adequate organ function:
  9. Females of 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 methods during the study and within 90 days after last dose of the study drug.

Exclusion criteria

Exclusion Criteria:

  1. Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular endothelial growth factor receptor (VEGFR) agents;
  2. Use of systematic anti-tumor therapies other than platinum-based chemotherapy in combination with /L1 within 4 weeks prior to the first dose;
  3. Presence of central nervous system (CNS) and/or cancerous meningitis (metastases to meninges);
  4. Toxicities associated with previous anti-tumor treatment that has not been resolved to Grade ≤ 1, except for alopecia and CTCAE Grade ≤ 2 peripheral neurotoxicity;
  5. Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
  6. Patients with active disorder or immunodeficiency or history of autoimmune disorder or immunodeficiency;
  7. Patients with evidence or history of obvious bleeding tendency within 2 months prior to the first dose;
  8. cardiovascular disorders;
  9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia;
  10. Patients who are unable to take oral medications, or with previous surgical history or severe gastrointestinal;
  11. Pregnant (with a positive pregnancy test) or lactating women within 5 years before screening.
  12. Patients with a history of malignant tumors excluding small cell lung cancer (SCLC) within 5 years before screening.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Surufatinib in combination with anti-PD-1/L1 therapy

    Surufatinib 250 mg orally once plus anti-PD-1/L1, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.

    Drug: Surufatinib · Drug: Anti-PD-1/L1

  • Experimental
    Anti-PD-1/L1 monotherapy

    Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy

    Drug: Anti-PD-1/L1

Interventions

  • The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.

  • DrugAnti-PD-1/L1

    Drug page: Immune checkpoint inhibitors

    Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.

    Also known as: Immune checkpoint inhibitor

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: About 18 months

Secondary outcomes

  1. Overall survival

    Overall survival (OS)

    Time frame: About 18 months

  2. Objective response rate

    Objective response rate (ORR) assessed per RECIST v1.1

    Time frame: About 18 months

  3. Disease control rate

    Disease control rate (DCR) assessed per RECIST v1.1

    Time frame: About 18 months

  4. Duration of response

    Duration of response (DoR) assessed per RECIST v1.1

    Time frame: About 18 months

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Jul 2024, 22 months.

Of 54 industry-sponsored phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 44. This study's 22 months is below that.

Counting every sponsor, half of 204 studies reached it within 46 months; a quarter within 29 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2022
First posted
Aug 22, 2022
StartActual
Sep 27, 2022
Primary completionActual
Jul 31, 2024
CompletionActual
Jul 31, 2024
Last update
Aug 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05509699
Responsible party
Sponsor
First posted
Aug 22, 2022
Start date
Sep 27, 2022
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Aug 29, 2025

Study contacts

Yi Hu, Postdoctor
principal investigator · Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Immune checkpoint inhibitors

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