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New immunotherapy cocktail aims to tackle tough lung cancer

NCT ID NCT07245446

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether adding extra immunotherapy drugs to standard chemotherapy can better control extensive-stage small cell lung cancer. About 180 adults who have not had prior treatment will be randomly assigned to one of three groups, all receiving the immunotherapy ivonescimab plus chemo, with some also getting cadonilimab or AK117. The goal is to see which combination shrinks tumors most safely.

What this could mean

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

Active substance
Ivonescimab (an immunotherapy drug) combined with chemotherapy (etoposide and carboplatin) and optionally cadonilimab or AK117
What this could lead to
If successful, this could offer a new first-line treatment option that shrinks tumors and controls extensive-stage small cell lung cancer for longer.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. Side effects from combining multiple drugs could be significant, and the added drugs may not improve outcomes over standard chemo-immunotherapy.

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 180 people

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

Started

Oct 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * No prior systemic therapy for ES-SCLC. * At least one measurable lesion as defined by RECIST v1.1. * Age 18 to 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed). * History of severe hypersensitivity to monoclonal antibodies. * Active autoimmune disease requiring systemic treatment within the past 2 years. * Significant cardiovascular disease. * Active hepatitis B or C, or HIV infection. * Interstitial lung disease or non-infectious pneumonitis. * Significant bleeding tendency or risk, including tumor invasion of major blood vessels. * Pregnancy or lactation. * Other active malignancies within 5 years prior to enrollment.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extensive-stage small cell lung cancer (es-SCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

  • Cancer Hospital Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100020, China

  • Shanghai Pulmonary Hospital Affiliated to Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710000, China

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