AzTrials
AzTrials

Non-small Cell Lung CancerPhase 1/2NCT04900363

A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLC

A Phase 1/2 study testing AK112 in people with Non-small Cell Lung Cancer, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is a Phase Ib/II study. All patients are stage IIIB/C 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 in subjects with advanced NSCLC whose tumors have a programmed cell… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
AK112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
21 May 2021to 9 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Has a histologically or cytologically confirmed diagnosis of NSCLC.
  • Has StageIIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]).
  • 18 to 75 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 obtained from either a core or excisional tumor biopsy.
  • Has a life expectancy of at least 3 months.
Show all 11Show fewer
  • 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 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

  • 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.
  • Has carcinomatous meningitis.
Show all 15Show fewer
  • 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). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • 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, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: A Phase Ib/II Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With Advanced NSCLC

This trial is a Phase Ib/II study. All patients are stage IIIB/C 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 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
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AK112Drug

    Subjects receive AK112 intravenously.

Study groups in NCT04900363
Study groupRoleWhat they receive
AK112ExperimentalSubjects receive AK112 monotherapy intravenously (IV) until no more benefits from treatment.
Receives: Drug: AK112

What is being measured

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

  1. Objective response rates (ORR)

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

    Measured: Up to approximately 2 years

  2. Number of participants with adverse events (AEs)

    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 approximately 2 years

  3. Progression-free survival (PFS)

    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 investigator or death due to any cause (whichever occurs first).

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. Disease control rate (DCR)

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

    Measured: up to 2 years

  2. Duration of response (DOR)

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

    Measured: up to 2 years

  3. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause.

    Measured: up to 2 years

  4. Maximum observed concentration (Cmax) of AK112

    Serum concentrations of AK112 in individual subjects at different time points after AK112 administration

    Measured: Up to 2 years

  5. Anti-drug antibodies (ADA)

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

    Measured: Up to 2 years

  6. PD-L1 expression

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

    Measured: Up to 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 posted25 May 2021
  2. Study start21 May 2021
  3. Primary completion28 Jun 2024
  4. Study completion9 Dec 2025

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900363
Sponsor's protocol ID
AK112-202
Status last verified
Feb 2026
First submitted
29 Apr 2021
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang L, Luo Y, Ren S, Zhang Z, Xiong A, Su C, Zhou J, Yu X, Hu Y, Zhang X, Dong X, Meng S, Wu F, Hou X, Dai Y, Song W, Li B, Wang ZM, Xia Y, Zhou C. A Phase 1b Study of Ivonescimab, a Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor Bispecific Antibody, as First- or Second-Line Therapy for Advanced or Metastatic Immunotherapy-Naive NSCLC. J Thorac Oncol. 2024 Mar;19(3):465-475. doi: 10.1016/j.jtho.2023.10.014. Epub 2023 Oct 23.

    PubMed 37879536

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK112 in people with 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 11 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: finished, as of the sponsor's last update on 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective response rates (ORR) (time frame: Up to approximately 2 years). The study lists 3 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 NCT04900363, which also lists 1 linked publication.

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 2 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in