Paclitaxel Polymeric Micelles Plus Ivonescimab in Recurrent or Refractory SCLC

NCT07819591 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-FXY-020-NEIKE
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCLC, Recurrent

Keywords

SCLC; Ivonescimab; Paclitaxel Polymeric Micelles; Recurrent; Refractory; Recurrent small cell lung cancer; Refractory small cell lung cancer

Outcome Measures

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.

  Up to 36 months

Secondary Outcomes (6)

• Disease Control Rate (DCR)

  Up to 36 months

• Clinical Benefit Rate (CBR)

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Progression-Free Survival (PFS)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (1)

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.

Drug: Paclitaxel Polymeric Micelles; Drug: Ivonescimab

Interventions

Paclitaxel Polymeric Micelles DRUG

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.

Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab

Ivonescimab DRUG

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.

Experimental: Paclitaxel Polymeric Micelles plus Ivonescimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Shaodong Hong: lead
• Akesobio: collaborator
• Shanghai Yizhong Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Recurrence; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shaodong Hong Hong, M.D., Ph.D.

CONTACT

+8615920527656; hongshd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Inverstigator

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)