Two-Drug combo targets Hard-to-Treat recurrent small cell lung cancer

NCT ID NCT07819591

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 47 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China