ClinicalTrials.gg
Not yet recruitingNCT07819591Updated Sep 15, 2026

Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC

A Phase 2 interventional study of Paclitaxel Polymeric Micelles and Ivonescimab in SCLC, Recurrent, sponsored by Shaodong Hong. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Primary conditionSmall Cell Lung CarcinomaRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Small Cell Lung Carcinoma
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's title name Small Cell Lung Carcinoma.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shaodong Hong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter, open-label, single-arm phase 2 study evaluating the efficacy and safety of ivonescimab combined with paclitaxel polymeric micelles in adults with recurrent or refractory small cell lung cancer after failure of platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.

Read the detailed description

This multicenter, open-label, single-arm phase II investigator-initiated study evaluates the efficacy and safety of ivonescimab combined with paclitaxel polymeric micelles in adults with recurrent or refractory small cell lung cancer after failure of platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Participants will receive ivonescimab 20 mg/kg intravenously on Day 1 every 3 weeks, followed at least 30 minutes later by paclitaxel polymeric micelles 230 mg/m² intravenously over at least 3 hours on Day 1 every 3 weeks. Paclitaxel polymeric micelles will be administered for up to 4 cycles. Ivonescimab may continue for up to 2 years or until disease progression, initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation. Tumor response will be assessed by investigators using RECIST v1.1 every 6 weeks during the first 12 months and every 9 weeks thereafter. The primary endpoint is objective response rate. Secondary endpoints include disease control rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and safety assessed using NCI CTCAE version 5.0.

02

Conditions studied

  • SCLC, Recurrent

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Keywords

  • SCLC
  • Ivonescimab
  • Paclitaxel Polymeric Micelles
  • Recurrent
  • Refractory
  • Recurrent small cell lung cancer
  • Refractory small cell lung cancer
03

In context

Small Cell Lung Carcinoma Reclassified

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.

This study's planned enrollment of 47 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Shaodong Hong is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Compared within Small Cell Lung Carcinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
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

  • Patients who have signed and agree to comply with the protocol.
  • Age ≥ 18 years.
  • or cytologically confirmed small-cell lung cancer after failure of platinum-based chemotherapy and /PD-L1 monoclonal antibody treatment.
  • At least one according to v1.1.
  • performance status 0 or 1.
  • Expected survival time ≥ 3 months.
  • Recovery of prior anti-tumor therapy toxicities to ≤ Grade 1 ( v5.0), except alopecia, fatigue, hyperpigmentation, and stabilized thyroid dysfunction (on hormone replacement) as specified in protocol.
  • Adequate cardiac function: (LVEF) ≥ 50%.
  • Adequate organ function: ≥ 1.5×10\^9/L, ≥ 100×10\^9/L, ≥ 90 g/L.
  • Total ≤ 1.5× (≤ 3×ULN if liver ); and ALT ≤ 2.5×ULN (≤ 5.0×ULN if liver metastases).
  • Creatinine ≤ 1.5×ULN or ≥ 50 mL/min (Cockcroft-Gault).
  • ≤ 1.5; APTT ≤ 1.5×ULN.
  • Women of : negative pregnancy test within 7 days before first dosing and non-lactating.
  • Effective from screening through 6 months after end of treatment for all patients with .

Exclusion criteria

Exclusion Criteria:

  • History of to paclitaxel micelles, ivonescimab (YS11/YS), or components of these products, or structurally related agents.
  • Prior systemic therapy with taxanes and/or anti-VEGF monoclonal antibodies.
  • Major surgery within 28 days before first investigational treatment.
  • Antitumor treatment within 4 weeks (or 5 half-lives for biologics, whichever is shorter), including chemotherapy, targeted therapy, biologics, immunotherapy, curative radiotherapy, major surgery, or large-field radiotherapy; small-molecule targeted therapy within 5 days before first dose (as protocol details).
  • Use of /CYP2C inhibitors or inducers within 7 days before first dose, or need to continue during study.
  • Use of traditional Chinese anti-tumor herbal medicines within 7 days before first dose, or need to continue during study.
  • Ongoing use of drugs known to prolong or induce torsades during study.
  • Symptomatic CNS involvement (including symptomatic ); brain- patients previously on must be tapered and off steroids for ≥14 days unless protocol allows exceptions.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Tumor encasement/invasion of major thoracoabdominal/other vital vessels judged unsafe for protocol treatment.
  • bleeding within 3 weeks before (e.g., hemoptysis, GI bleeding, bleeding ulcer).
  • Inflammatory bowel disease, major bowel resection history, immune-related colitis, bowel obstruction, chronic diarrhea, or Gilbert syndrome.
  • Other within 5 years, except adequately controlled basal cell carcinoma, cervical CIS, or DCIS >3 years.
  • Serious cardiac/cerebrovascular disease: class ≥2 heart failure, acute coronary syndrome within 6 months, or stroke//hemorrhagic stroke within 6 months.
  • Significant arrhythmia (complete LBBB, third-degree AV block, uncontrolled ventricular/atrial arrhythmia; stable controlled arrhythmia exceptions may apply).
  • Active unstable thromboembolic disease requiring treatment within 6 months (except >4-week old peripheral line thrombosis).
  • Uncontrolled systemic diseases likely to interfere with protocol conduct, including uncontrolled hypertension, diabetes, active bleeding, active /C/ (including HBV DNA >10000 copies/mL when HBsAg positive), or other active infection.
  • disease requiring systemic treatment in prior 2 years (excluding replacement hormones).
  • Current or clinically significant history of ILD, or ILD/grade ≥2 radiation pneumonitis.
  • Severe neurologic or psychiatric disease.
  • Unhealed wound, ulcer, or fracture within 4 weeks before informed consent.
  • Planned or received within 28 days before randomization/first dose.
  • Pregnancy or breastfeeding.
  • Any other condition the investigator judges to make trial participation inappropriate.
Terms in these criteria, in plain language(35)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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.

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.

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.

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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

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

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab

    Ivonescimab 20 mg/kg is administered intravenously on Day 1 every 3 weeks. At least 30 minutes later, paclitaxel polymeric micelles 230 mg/m² are administered intravenously over at least 3 hours on Day 1 every 3 weeks. Paclitaxel polymeric micelles are given for up to 4 cycles. Ivonescimab continues for up to 2 years or until disease progression, initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation.

    Drug: Paclitaxel Polymeric Micelles · Drug: Ivonescimab

Interventions

  • DrugPaclitaxel Polymeric Micelles

    Paclitaxel polymeric micelles 230 mg/m² are administered intravenously over at least 3 hours on Day 1 of each 3-week cycle, at least 30 minutes after ivonescimab infusion. Treatment is given for a maximum of 4 cycles or until initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation.

  • Ivonescimab 20 mg/kg is administered intravenously on Day 1 of each 3-week cycle. It is administered before paclitaxel polymeric micelles. Treatment continues for up to 2 years or until disease progression, initiation of new antitumor therapy, unacceptable toxicity, withdrawal of consent, death, or another protocol-defined reason for discontinuation.

06

What researchers measure

Primary outcomes

  1. Outcome Objective Response Rate (ORR) assessed by RECIST v1.1

    The percentage of participants with a confirmed complete response or partial response, assessed by investigators according to RECIST version 1.1.

    Time frame: Up to 36 months

Secondary outcomes

  1. Disease Control Rate (DCR)

    The percentage of participants with complete response, partial response, or stable disease, assessed by investigators according to RECIST version 1.1.

    Time frame: Up to 36 months

  2. Clinical Benefit Rate (CBR)

    The percentage of participants with an objective response or stable disease lasting at least 4 months, assessed by investigators according to RECIST version 1.1.

    Time frame: Up to 36 months

  3. Duration of Response (DOR)

    The time from the first documented complete or partial response to the first documented disease progression, recurrence, or death from any cause.

    Time frame: Up to 36 months

  4. Progression-Free Survival (PFS)

    The time from first study treatment to documented disease progression or death from any cause, whichever occurs first.

    Time frame: Up to 36 months

  5. Overall Survival (OS)

    The time from first study treatment to death from any cause; participants alive at analysis are censored at the last known alive date or clinical cutoff date.

    Time frame: Up to 36 months

  6. Number of participants with Adverse Events

    Incidence and severity of adverse events, serious adverse events, laboratory abnormalities, vital-sign abnormalities, physical examination findings, and electrocardiogram abnormalities; severity is assessed using NCI CTCAE version 5.0.

    Time frame: From first dose through 30 days after the last study treatment, up to approximately 25 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — De-identified individual participant data and data dictionaries from this investigator-initiated Phase II oncology study will not be shared at this time due to current sponsor/institutional policy, data governance requirements, and pending legal/ethics arrangements.

No publications or documents are linked to this record.

09

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

Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.

Of 150 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 87. This study's planned 26 months is below that.

Counting every sponsor, half of 203 studies reached it within 47 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
Jul 24, 2026
First posted
Sep 15, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Dec 1, 2028
Last update
Sep 15, 2026
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 Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07819591
Lead sponsor
Shaodong Hong
Collaborators
Akesobio, Shanghai Yizhong Pharmaceutical Co., Ltd.
Responsible party
Shaodong Hong (Principle Inverstigator, Sun Yat-sen University) — Sponsor-investigator
First posted
Sep 15, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Sep 15, 2026

Study contacts

Shaodong Hong Hong, M.D., Ph.D.
Contact
hongshd@sysucc.org.cn
+8615920527656

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. 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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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ivonescimab

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