AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

March 5, 2026 updated by: Akeso

A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

This trial is a Phase Ib/II 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 safety and efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Pulmonary Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a histologically or cytologically confirmed diagnosis of NSCLC.
  • Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC 8th]).
  • 18-75 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.
  • Has a life expectancy of at least 3 months.
  • 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 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, during and for 120 days after the last dose of study treatment.

Exclusion Criteria:

  • 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.
  • 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).
  • Has a 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: docetaxel
Drug: Docetaxel
Subjects receive docetaxel intravenously.
Experimental: AK112 plus AK104
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Experimental: AK112, AK104 plus docetaxel
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Drug: Docetaxel
Subjects receive docetaxel intravenously.
Experimental: AK112, AK104 dose 1 plus carboplatin and paclitaxel
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Drug: paclitaxel
Subjects receive paclitaxel intravenously.
Drug: Carboplatin
Subjects receive carboplatin intravenously.
Experimental: AK112, AK104 dose 1 plus carboplatin and pemetrexed
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Drug: pemetrexed
Subjects receive pemetrexed intravenously.
Drug: Carboplatin
Subjects receive carboplatin intravenously.
Experimental: AK112, AK104 dose 2 plus carboplatin and paclitaxel
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Drug: paclitaxel
Subjects receive paclitaxel intravenously.
Drug: Carboplatin
Subjects receive carboplatin intravenously.
Experimental: AK112, AK104 dose 2 plus carboplatin and pemetrexed
Drug: AK112
Subjects receive AK112 intravenously.
Drug: AK104
Subjects receive AK104 intravenously.
Drug: pemetrexed
Subjects receive pemetrexed intravenously.
Drug: Carboplatin
Subjects receive carboplatin intravenously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety reflected by AE
Time Frame: Up to 2 approximately years
Safety will be reflected by AE, which 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.
Up to 2 approximately years
ORR per RECIST v1.1
Time Frame: Up to 2 approximately years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Up to 2 approximately years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: Up to 2 approximately years
Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.
Up to 2 approximately years
ADA
Time Frame: Up to 2 approximately years
Number of subjects with detectable anti-drug antibodies (ADA).
Up to 2 approximately years
DoR per RECIST v1.1
Time Frame: Up to 2 approximately years
Duration of response (DoR) assessed according to RECIST v1.1.
Up to 2 approximately years
DCR per RECIST v1.1
Time Frame: Up to 2 approximately years
Disease control rate (DCR) assessed according to RECIST v1.1.
Up to 2 approximately years
TTR per RECIST v1.1
Time Frame: Up to 2 approximately years
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Up to 2 approximately years
PFS per RECIST v1.1
Time Frame: Up to 2 approximately years
Progression-free survival (PFS) is defined as the time from the date of Initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Up to 2 approximately years
AK112 serum concentration
Time Frame: Up to 2 approximately years
The serum concentration of AK112 of individual subjects at different time points.
Up to 2 approximately years
AK104 serum concentration
Time Frame: Up to 2 approximately years
The serum concentration of AK104 of individual subjects at different time points.
Up to 2 approximately years
PD-L1 expression
Time Frame: Up to 2 approximately years
The correlationship between PD-L1 expression and efficacy.
Up to 2 approximately years
ctDNA
Time Frame: Up to 2 approximately years
The correlationship between ctDNA detection and efficacy.
Up to 2 approximately years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK112-208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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