Two-Drug combo targets Hard-to-Treat recurrent small cell lung cancer
NCT ID NCT07819591
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing a combination of paclitaxel polymeric micelles and ivonescimab in adults with small cell lung cancer that has returned or stopped responding after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. The phase 2 trial aims to see how many participants' tumors shrink and how long the response lasts. About 47 people will receive the drugs intravenously every three weeks for up to four cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of paclitaxel polymeric micelles and ivonescimab
- What this could lead to
- If the combination works, it could offer a new treatment option for small cell lung cancer that has come back after standard chemotherapy and immunotherapy.
- What could go wrong
- This is a small, single-arm phase 2 trial with no control group, so any benefit seen may not hold up in larger studies. The combination may cause side effects that outweigh its benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 47 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China