SCLC, RecurrentPhase 2NCT07819591
Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC
A Phase 2 study testing Paclitaxel Polymeric Micelles and Ivonescimab in people with SCLC, Recurrent, run by Shaodong Hong at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Recurrent
- What is being tested?
- Paclitaxel Polymeric Micelles and Ivonescimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have signed informed consent and agree to comply with the protocol.
- Age ≥ 18 years.
- Histologically or cytologically confirmed relapsed small-cell lung cancer after failure of platinum-based chemotherapy and PD-1/PD-L1 monoclonal antibody treatment.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0 or 1.
- Expected survival time ≥ 3 months.
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- Recovery of prior anti-tumor therapy toxicities to ≤ Grade 1 (NCI-CTCAE v5.0), except alopecia, fatigue, hyperpigmentation, and stabilized thyroid dysfunction (on hormone replacement) as specified in protocol.
- Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.
- Adequate organ function: ANC ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.
- Total bilirubin ≤ 1.5×ULN (≤ 3×ULN if liver metastases); AST and ALT ≤ 2.5×ULN (≤ 5.0×ULN if liver metastases).
- Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
- INR ≤ 1.5; APTT ≤ 1.5×ULN.
- Women of childbearing potential: negative pregnancy test within 7 days before first dosing and non-lactating.
- Effective contraception from screening through 6 months after end of treatment for all patients with reproductive potential.
Who cannot join
- History of hypersensitivity to paclitaxel micelles, ivonescimab (YS11/YS), or components of these investigational 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 CYP3A/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.
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- Ongoing use of drugs known to prolong QT interval or induce torsades during study.
- Symptomatic CNS involvement (including symptomatic brain metastases); brain-metastasis patients previously on steroids 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.
- Clinically significant bleeding within 3 weeks before informed consent (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 malignancy within 5 years, except adequately controlled basal cell carcinoma, cervical CIS, or DCIS >3 years.
- Serious cardiac/cerebrovascular disease: NYHA class ≥2 heart failure, acute coronary syndrome within 6 months, or stroke/TIA/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 hepatitis B/C/HIV (including HBV DNA >10000 copies/mL when HBsAg positive), or other active infection.
- Autoimmune 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 live vaccine within 28 days before randomization/first dose.
- Pregnancy or breastfeeding.
- Any other condition the investigator judges to make trial participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of Paclitaxel Polymeric Micelles Combined With Ivonescimab in Patients With Recurrent or Refractory Small Cell Lung Cancer After Failure of Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Therapy
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.
- Conditions
- SCLC, Recurrent
- Being tested
- Paclitaxel Polymeric Micelles, Ivonescimab
- Keywords
- SCLC, Ivonescimab, Paclitaxel Polymeric Micelles, Recurrent, Refractory, Recurrent small cell lung cancer, Refractory small cell lung cancer
- Medical subject headings
- Recurrence, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Polymeric MicellesDrug
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.
IvonescimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab | Experimental | 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. Receives: Drug: Paclitaxel Polymeric Micelles; Drug: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Secondary outcomes (6)
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.
Measured: Up to 36 months
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.
Measured: Up to 36 months
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.
Measured: Up to 36 months
Progression-Free Survival (PFS)
The time from first study treatment to documented disease progression or death from any cause, whichever occurs first.
Measured: Up to 36 months
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.
Measured: Up to 36 months
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.
Measured: From first dose through 30 days after the last study treatment, up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, RecurrentStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Ivonescimab 20 mg/kg intravenously every 3 weeks combined with paclitaxel polymeric micelles 230 mg/m2 intravenously every 3 weeks. Paclitaxel polymeric micelles will be administered for up to 4 cycles; ivonescimab may continue until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal, or up to approximately 2 years.
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaodong Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Akesobio, Shanghai Yizhong Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Shaodong Hong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819591
- Sponsor's protocol ID
- 2026-FXY-020-NEIKE
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Paclitaxel Polymeric Micelles Combined With Ivonescimab in Patients With Recurrent or Refractory Small Cell Lung Cancer After Failure of Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Therapy
- ClinicalTrials.gov ID
- NCT07819591
- Acronym / sponsor ID
- 2026-FXY-020-NEIKE
- Conditions
- SCLC, Recurrent
- Keywords
- SCLC, Ivonescimab, Paclitaxel Polymeric Micelles, Recurrent, Refractory, Recurrent small cell lung cancer, Refractory small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Shaodong HongUniversity, hospital or other
- Collaborators
- Akesobio, Shanghai Yizhong Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Sep 2026 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ivonescimab 20 mg/kg intravenously every 3 weeks combined with paclitaxel polymeric micelles 230 mg/m2 intravenously every 3 weeks. Paclitaxel polymeric micelles will be administered for up to 4 cycles; ivonescimab may continue until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal, or up to approximately 2 years.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab | Experimental | Drug: Paclitaxel Polymeric Micelles, Drug: IvonescimabIvonescimab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients who have signed informed consent and agree to comply with the protocol.
- Age ≥ 18 years.
- Histologically or cytologically confirmed relapsed small-cell lung cancer after failure of platinum-based chemotherapy and PD-1/PD-L1 monoclonal antibody treatment.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0 or 1.
Key exclusion criteria (24 listed)
- History of hypersensitivity to paclitaxel micelles, ivonescimab (YS11/YS), or components of these investigational 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 CYP3A/CYP2C inhibitors or inducers within 7 days before first dose, or need to continue during study.
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 |
|---|---|---|
| Paclitaxel Polymeric MicellesPaclitaxel 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. | Drug | Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab |
| IvonescimabIvonescimab 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. | Drug | Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab |
Primary outcome
Outcome Objective Response Rate (ORR) assessed by RECIST v1.1
Time frame: Up to 36 months
The percentage of participants with a confirmed complete response or partial response, assessed by investigators according to RECIST version 1.1.
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 36 months
Clinical Benefit Rate (CBR)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Number of participants with Adverse Events
Time frame: From first dose through 30 days after the last study treatment, up to approximately 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
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 Paclitaxel Polymeric Micelles and Ivonescimab in people with SCLC, Recurrent, run by Shaodong Hong 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 14 inclusion and 24 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: opening soon, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaodong Hong Hong, M.D., Ph.D. (+8615920527656, hongshd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Objective Response Rate (ORR) assessed by RECIST v1.1 (time frame: Up to 36 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 15 Sep 2026.