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NSCLCPhase 1/2NCT05636267

Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

A Phase 1/2 study testing AK119, AK112 and Pemetrexed in people with NSCLC, run by Akeso at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
AK119, AK112 and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
10 Feb 2023to 15 Apr 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

  • Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
  • Age ≥ 18 and ≤ 75, male or female.
  • Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
  • EGFR activating mutation confirmed by tumor histology, cytology or hematology.
  • Failed to previous EGFR-TKI treatment.
  • ECOG performance status 0 to1.
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  • Life expectancy ≥3 months.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate organ function.

Who cannot join

  • Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
  • Have suffered from the second primary active malignant tumor in the past 3 years.
  • There are other driving gene mutations that can obtain effective treatment.
  • Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
  • Symptomatic central nervous system metastases.
  • The toxicity of previous anti-tumor therapy has not been alleviated.
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  • Uncontrolled massive ascites, pleural effusion or pericardial effusion.
  • Active autoimmune diseases in the past 2 years.
  • History of interstitial lung disease or noninfectious pneumonitis.
  • Suffering from clinically significant cardiovascular or cerebrovascular diseases.
  • History of severe bleeding tendency or coagulation dysfunction.
  • History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months.
  • Serious infection in the past 4 weeks.
  • Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks.
  • History of human immunodeficiency virus (HIV) infection.
  • History of severe hypersensitivity reactions to other mAbs.
  • History of organ transplantation.
  • Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Phase Ib/II Study of AK119 and AK112 With or Without Chemotherapy in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.

Conditions
NSCLC
Being tested
AK119, AK112, Pemetrexed, Carboplatin

What participants receive

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

  • AK119Drug

    AK119 IV every 3 weeks.

  • AK112Drug

    AK112 IV every 3 weeks.

  • PemetrexedDrug

    Pemetrexed IV every 3 weeks.

  • CarboplatinDrug

    Carboplatin IV every 3 weeks.

Study groups in NCT05636267
Study groupRoleWhat they receive
AK119 + AK112ExperimentalSubjects will receive AK119 plus AK112 via intravenously (IV) Q3W, up to 2 years.
Receives: Drug: AK119; Drug: AK112
AK119 + AK112 + Pemetrexed + CarboplatinExperimentalSubjects will receive AK119 and AK112 plus pemetrexed and carboplatin via intravenously (IV) Q3W, up to 4 cycles. Afterward, AK119 and AK112 plus pemetrexed will continue to be treated up to 2 years.
Receives: Drug: AK119; Drug: AK112; Drug: Pemetrexed; Drug: Carboplatin
AK112ExperimentalSubjects will receive AK112 monotherapy via intravenously (IV) Q3W, up to 2 years.
Receives: Drug: AK112

What is being measured

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

  1. Number of subjects with dose limiting toxicities (DLTs)

    DLTs will be assessed during the first 3 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

    Measured: During the first 3 weeks

  2. Number of subjects with adverse events (AEs)

    AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

    Measured: From the time of informed consent signed through 90 days after the last dose of study drug

  3. Objective response rate (ORR)

    ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).

    Measured: Up to 2 years

  3. Duration of response (DoR)

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  4. Time to response (TTR)

    TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

    Measured: Up to 2 years

  5. Overall survival (OS)

    OS defined as the time from the first dose to death from any cause.

    Measured: Up to 2 years

  6. Maximum observed concentration (Cmax) of AK119 and AK112

    The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration.

    Measured: From first dose of study drug through last dose

  7. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

    Measured: From first dose of study drug through last dose

Timeline

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

  1. First posted5 Dec 2022
  2. Study start10 Feb 2023
  3. Primary completion24 Feb 2025
  4. Study completion15 Apr 2025

Why it stopped: Terminated due to sponsor strategic development reprioritization.

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05636267
Sponsor's protocol ID
AK119-201
Status last verified
Mar 2023
First submitted
9 Nov 2022
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK119, AK112 and Pemetrexed in people with NSCLC, 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 9 inclusion and 18 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: stopped early, 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 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 was stopped early (reason given: Terminated due to sponsor strategic development reprioritization.). Results are not available in the source record.

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?

Number of subjects with dose limiting toxicities (DLTs) (time frame: During the first 3 weeks). 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 NCT05636267.

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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