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New combo shows promise for tough lung cancer

NCT ID NCT06478043

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This phase 2 study tested a combination of two drugs—ivonescimab (AK112) and irinotecan liposome—in 60 people with extensive-stage small-cell lung cancer whose disease had worsened after standard first-line therapy. The goal was to see if the combo could slow cancer growth and shrink tumors. Participants received the drugs intravenously every 2 to 3 weeks. The study is now complete, and results will show how well the treatment worked and what side effects occurred.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivonescimab (AK112) and irinotecan liposome
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced small-cell lung cancer who have run out of standard therapies.
What could go wrong
This is a small, early-phase study with only 60 participants and no comparison group, so results may not apply broadly. The drugs can cause serious side effects like low blood cell counts and immune-related reactions.

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

60 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

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 to 75 years

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: 1. 18 to 75 years old (at the time of inform consent obtained). 2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). 3. Histologically confirmed SCLC. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months. 6. SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors. 7. At least one measurable tumor lesion according to RECIST v1.1. 8. Adequate organ function. 9. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: 1. Patients with other cancer in 5 years. 2. Undergone anti-angiogenic therapy prior to the first dose of study treatment. 3. Evidence and history of severe bleeding tendency. 4. History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs. 5. Active central nervous system (CNS) metastases. 6. Active infection requiring systemic therapy. 7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions. 8. Active hepatitis B/C, or HIV infection. 9. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment. 10. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation. 11. History of alcohol abuse, psychotropic substance abuse or drug abuse. 12. Pregnant or lactating women. 13. Other conditions considered unsuitable for this study by the investigator.

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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.

Contacts and locations

Locations

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.