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Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT07245446

A Study of Ivonescimab in First-Line ES-SCLC

A Phase 2 study testing Ivonescimab, Cadonilimab and AK117 in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Akeso at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ivonescimab, Cadonilimab and AK117
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
3 sitesChina
Study dates
29 Oct 2025to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Significant bleeding tendency or risk, including tumor invasion of major blood vessels.
  • Pregnancy or lactation.
  • Other active malignancies within 5 years prior to enrollment.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wenting Li contact

+86-18116403289

wenting01.li@akesobio.com

China3 sites, 3 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100020

    Zhijie Wang, MD, PhD, +86-10-87788525, wangzj@cicams.ac.cn

    Zhijie Wang, MD, PhD

    Not yet recruiting

  • Shanghai Pulmonary Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200433

    Shengxiang Ren, MD, PhD, +86-21-65102117, harry_ren@126.com

    Shengxiang Ren, MD, PhD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

    Yu Yao, MD, PhD, +86-13572101611, 13572101611@163.com

    Yu Yao, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

The main questions the study aims to answer are:

Read more
  • What side effects do participants experience from these combination treatments?
  • How well do the treatments work to shrink tumors?

Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:

  • Group 1 will also receive an additional drug called AK117.
  • Group 2 will also receive a different additional drug called Cadonilimab.
  • Group 3 will receive Ivonescimab and chemotherapy only.

Participants will:

  • Be assigned by chance to one of the three groups.
  • Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group.
  • If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years.
  • Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
Being tested
Ivonescimab, Cadonilimab, AK117, Etoposide, Carboplatin (AUC 5)
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvonescimabDrug

    Administered intravenously at a specified dose and frequency.

  • CadonilimabDrug

    Administered intravenously at a specified dose and frequency.

  • AK117Drug

    Administered intravenously at a specified dose and frequency.

  • EtoposideDrug

    Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.

  • Carboplatin (AUC 5)Drug

    Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.

Study groups in NCT07245446
Study groupRoleWhat they receive
Ivonescimab + AK117 + ChemotherapyExperimentalNot described
Receives: Drug: Ivonescimab; Drug: AK117; Drug: Etoposide; Drug: Carboplatin (AUC 5)
Ivonescimab + Cadonilimab + ChemotherapyExperimentalNot described
Receives: Drug: Ivonescimab; Drug: Cadonilimab; Drug: Etoposide; Drug: Carboplatin (AUC 5)
Ivonescimab + ChemotherapyExperimentalNot described
Receives: Drug: Ivonescimab; Drug: Etoposide; Drug: Carboplatin (AUC 5)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    The proportion of participants achieving a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to approximately 2 years.

  2. Incidence of Adverse Events (AEs)

    The number and percentage of participants experiencing any Adverse Event (AE). An AE is defined as any untoward medical occurrence in a participant administered a study drug, which may not have a causal relationship with the treatment. Severity will be graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

    Measured: From first dose up to 90 days after last dose.

Secondary outcomes (7)

  1. Disease Control Rate (DCR)

    The proportion of participants achieving a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator per RECIST v1.1.

    Measured: Up to approximately 2 years.

  2. Duration of Response (DoR)

    For responders (participants achieving CR or PR), DoR is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.

    Measured: Up to approximately 2 years.

  3. Time to Response (TTR)

    For responders (participants achieving CR or PR), TTR is defined as the time from the start of study treatment to the first documented objective response (CR or PR), per RECIST v1.1.

    Measured: Up to approximately 2 years.

  4. Progression-Free Survival (PFS)

    PFS is defined as the time from the start of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to approximately 2 years.

  5. Overall Survival (OS)

    OS is defined as the time from the start of study treatment to death from any cause.

    Measured: Up to approximately 5 years.

  6. Serum concentrations of Ivonescimab, Cadonilimab, and AK117

    Serum concentrations of Ivonescimab, Cadonilimab, and AK117 will be measured to characterize the pharmacokinetic (PK) profiles.

    Measured: Up to approximately 2 years.

  7. Incidence of Anti-drug Antibodies (ADA)

    The immunogenicity will be assessed by the incidence of participants who develop detectable anti-drug antibodies (ADA) against Ivonescimab, Cadonilimab, and/or AK117.

    Measured: Up to approximately 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start29 Oct 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245446
Sponsor's protocol ID
AK112-214
Status last verified
Nov 2025
First submitted
29 Sep 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab, Cadonilimab and AK117 in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Akeso at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenting Li (+86-18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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