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Non-Small Cell Lung CancerPhase 2AGA TKI NSCLCNCT07158840

AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment

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

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
5 Sep 2025to Jun 2029
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

  • Signed the Informed Consent Form (ICF) voluntarily。
  • Participants must be aged between 18 and 75 years (inclusive), regardless of gender.
  • ECOG performance status of 0 or 1.
  • With a life expectancy of ≥3 months.
  • Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC.
  • Prior to enrollment, participants must have at least one actionable genomic alteration (AGA) confirmed by tumor histology, cytology, or blood-based testing, including: EGFR, ALK, ROS1, NTRK, RET, BRAF and MET. Participants must provide a prior AGA test report; otherwise, AGA testing must be performed at the study site or at a site-designated laboratory before enrollment.
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  • Previous treatment failure with an AGA-targeted TKI.
  • At least one measurable extracranial lesion as defined by RECIST v1.1.
  • Adequate organ function confirmed.

Who cannot join

  • Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component.
  • AGA test report showing the presence of a common EGFR sensitizing mutation.
  • Prior receipt of immunotherapy.
  • Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs.
  • Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study.
  • Receipt of AGA-targeted TKI therapy within 2 weeks prior to the first dose; receipt of non-specific immunomodulatory therapy within 2 weeks prior to the first dose.
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  • Imaging during the screening period shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator determines that study participation would pose a bleeding risk.
  • Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels.
  • Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible.
  • History of malignancy other than NSCLC within 3 years prior to the first dose; participants with other malignancies that have been cured by local treatment are allowed.
  • Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
  • History of major medical conditions within 1 year prior to the first dose.

Trial locations and contacts

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

Ting Liu contact

0760-89873925

clinicaltrials@akesobio.com

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou

    Chongrui Xu, xuchongrui@gdph.org.cn

    Yilong Wu

Other trials in China

About this study

Official title: A Single Arm, Multi-center, Phase II Study of AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment

AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment

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

    AK112 Monotherapy

Study groups in NCT07158840
Study groupRoleWhat they receive
Experimental ArmExperimentalNot described
Receives: Drug: AK112

What is being measured

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

  1. Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1.

    Measured: up to 2 years

Secondary outcomes (9)

  1. Overall survival (OS)

    From date of enrollment until the date of death from any cause

    Measured: up to 2 years

  2. Progression-free survival (PFS)

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

    Measured: up to 2 years

  3. Duration of response (DoR)

    Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: up to 2 years

  4. Disease control rate (DCR)

    Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1

    Measured: up to 2 years

  5. Time to response (TTR)

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

    Measured: up to 2 years

  6. Percentage of participants with adverse event (AE)

    The percentage of participants experiencing an adverse event (AE) and the severity of AEs will be assessed

    Measured: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years

  7. Observed concentrations of AK112

    The endpoints for assessment of Pharmacokinetics (PK) of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration

    Measured: From date of enrollment until the end of treatment, assessed up to 2 years

  8. Number of participants who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK112 will be assessed by summarizing the number of participants who develop detectable antidrug antibodies (ADAs)

    Measured: From first dose of AK112 through 90 days after last dose of AK112,up to 2 years

  9. Number of participants with programmed cell death ligand 1 (PD-L1) expression positive who achieve CR/PR

    Measured: From date of enrollment until the end of treatment, assessed 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 posted8 Sep 2025
  2. Study start5 Sep 2025 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionJun 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158840
Sponsor's protocol ID
AK112-215
Acronym
AGA TKI NSCLC
Status last verified
Sep 2025
First submitted
14 Aug 2025
Last updated
8 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 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 Ting Liu (0760-89873925, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator (time frame: up to 2 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 NCT07158840.

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 8 Sep 2025.

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