A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

June 9, 2026 updated by: Akeso

A Phase II Trial of AK104 in Combination With Docetaxel in Subjects With Advanced Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Treatment With One Prior Anti-PD-1/PD-L1 Monoclonal Antibody (mAb)

Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu 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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 to 75 years old.
  2. Have a life expectancy of at least 3 months.
  3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
  5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
  6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
  7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.
  8. Has adequate organ function.

Exclusion Criteria:

  1. Undergone major surgery within 30 days prior to the first dose of study treatment.
  2. Active central nervous system (CNS) metastases.
  3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
  4. Active Hepatitis B or Hepatitis C.
  5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
  6. Has received treatment with docetaxel.
  7. History of severe bleeding tendency or coagulation disorder.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK104 plus Docetaxel
AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity.
Drug: AK104
IV infusion,Specified dose on specified days
Drug: Docetaxel
IV infusion,Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of patients with Adverse Events (AEs)
Time Frame: Up to approximately 2 years
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Up to approximately 2 years
Disease control rate (DCR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to response (TTR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression free survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

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)

May 13, 2022

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104-215

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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