Paclitaxel micelles with ivonescimab for small cell lung cancer that returned

Trial details

Who runs it

Shaodong Hong

Trial code

NCT07819591

Record updated

15 September 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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; 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; Clinically significant bleeding within 3 weeks before informed consent (e.g., hemoptysis, GI bleeding, bleeding ulcer); Autoimmune disease requiring systemic treatment in prior 2 years (excluding replacement hormones); Unhealed wound, ulcer, or fracture within 4 weeks before informed consent; Planned or received live vaccine within 28 days before randomization/first dose; Inflammatory bowel disease, major bowel resection history, immune-related colitis, bowel obstruction, chronic diarrhea, or Gilbert syndrome; 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; Current or clinically significant history of ILD, or ILD/grade ≥2 radiation pneumonitis; Severe neurologic or psychiatric disease; Any other condition the investigator judges to make trial participation inappropriate; Ongoing use of drugs known to prolong QT interval or induce torsades during study; Other malignancy within 5 years, except adequately controlled basal cell carcinoma, cervical CIS, or DCIS >3 years; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; Tumor encasement/invasion of major thoracoabdominal/other vital vessels judged unsafe for protocol treatment; Pregnancy or breastfeeding.

ClinicalTrials.gov NCT07819591