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Advanced Non-small-cell Lung CancerPhase 3NCT05499390

AK112 in Advanced Non-Small Cell Lung Cancer

A Phase 3 study testing AK112 and Pembrolizumab in people with Advanced Non-small-cell Lung Cancer, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-small-cell Lung Cancer
What is being tested?
AK112 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
1 siteChina
Study dates
9 Nov 2022to 31 Dec 2026
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically or cytologically confirmed diagnosis of NSCLC.
  • Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]).
  • ≥18 years old (at the time consent is obtained).
  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
  • Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
  • Has a life expectancy of at least 3 months.
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  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team.
  • Has no EGFR-sensitive mutations or ALK gene translocations.
  • Has positive PD-L1 expression in tumor tissue.
  • Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
  • Has adequate organ function.
  • Has recovered from the effects of any prior radiotherapy or surgery.
  • 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.

Who cannot join

  • Has any histologically small cell carcinoma component.
  • Is currently participating in a study of an investigational agent or using an investigational device.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment.
  • Has undergone major surgery within 30 days of Study Day 1.
  • Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases.
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  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Has an active infection requiring systemic therapy.
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
  • Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
  • Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai

Other trials in China

About this study

Official title: A Randomized Controlled, Multi-center Phase III Clinical Trial of AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

Being tested
AK112, Pembrolizumab

What participants receive

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

  • AK112Drug

    Subjects receive AK112 intravenously.

  • PembrolizumabDrug

    Subjects receive Pembrolizumab intravenously.

Study groups in NCT05499390
Study groupRoleWhat they receive
AK112ExperimentalSubjects receive AK112 monotherapy intravenously (IV), selected dose.
Receives: Drug: AK112
PembrolizumabActive comparatorSubjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.
Receives: Drug: Pembrolizumab

What is being measured

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

  1. PFS assessed by IRRC per RECIST v1.1

    Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).

    Measured: Up to 2 approximately years

Secondary outcomes (13)

  1. OS

    Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.

    Measured: Up to 2 approximately years

  2. ORR assessed by IRRC per RECIST v1.1

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

    Measured: Up to 2 approximately years

  3. DoR assessed by IRRC per RECIST v1.1

    Duration of response (DoR) assessed according to RECIST v1.1.

    Measured: Up to 2 approximately years

  4. DCR assessed by IRRC per RECIST v1.1

    Disease control rate (DCR) assessed according to RECIST v1.1.

    Measured: Up to 2 approximately years

  5. TTR assessed by IRRC per RECIST v1.1

    Time to response (TTR) is defined as the time to response base on RECIST v1.1.

    Measured: Up to 2 approximately years

  6. PFS assessed by investigator per RECIST v1.1

    Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to 2 approximately years

  7. ORR assessed by the investigator per RECIST v1.1

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

    Measured: Up to 2 approximately years

  8. DoR assessed by the investigator per RECIST v1.1

    Duration of response (DoR) assessed according to RECIST v1.1.

    Measured: Up to 2 approximately years

  9. DCR assessed by the investigator per RECIST v1.1

    Disease control rate (DCR) assessed according to RECIST v1.1.

    Measured: Up to 2 approximately years

  10. TTR assessed by the investigator per RECIST v1.1

    Time to response (TTR) is defined as the time to response base on RECIST v1.1.

    Measured: Up to 2 approximately years

  11. AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: Up to 2 approximately years

  12. ADA

    Number of subjects with detectable anti-drug antibodies (ADA).

    Measured: Up to 2 approximately years

  13. PD-L1 expression

    The correlationship between PD-L1 expression and AK112 anti-tumor activity.

    Measured: Up to 2 approximately years

Timeline

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

  1. First posted12 Aug 2022
  2. Study start9 Nov 2022
  3. Primary completion29 Jan 2024
  4. Study completion31 Dec 2026 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499390
Sponsor's protocol ID
AK112-303
Status last verified
Mar 2026
First submitted
11 Aug 2022
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang L, Yao W, Shen H, Xie C, Chen H, Chen K, Su W, Gan X, Zhuo M, Chen E, Xu Z, Zhang Y, Wang M, Ma R, Wu H, Zhang Z, Ye F, Moore AC, Zhou C. Plain language summary: comparing ivonescimab with pembrolizumab in people with PD-L1-positive non-small cell lung cancer in the HARMONi-2 study. Future Oncol. 2026 Jan;22(1):27-36. doi: 10.1080/14796694.2025.2601138. Epub 2025 Dec 28.

    PubMed 41457351

  • Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, Zhong H, Li J, Cheng Y, Sun Y, Ge H, Yao J, Shi Q, Zhou M, Chen B, Han Z, Wang J, Bu Q, Zhao Y, Chen J, Nie L, Li G, Li X, Yu X, Ji Y, Sun D, Ai X, Chu Q, Lin Y, Hao J, Huang D, Zhou C, Shan J, Yang H, Liu X, Wang J, Shang Y, Mei X, Yang J, Lu D, Hu M, Wang ZM, Li B, Xia M, Zhou C. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. Lancet. 2025 Mar 8;405(10481):839-849. doi: 10.1016/S0140-6736(24)02722-3.

    PubMed 40057343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK112 and Pembrolizumab in people with Advanced Non-small-cell Lung Cancer, run by Akeso at 1 site 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 14 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by IRRC per RECIST v1.1 (time frame: Up to 2 approximately years). 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 NCT05499390, which also lists 2 linked publications.

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 9 Mar 2026.

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