Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer (NSCLC)

April 7, 2026 updated by: Akeso

A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy

This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

536

Phase

  • Phase 3

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 Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Caicun Zhou

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
  • Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected life expectancy of at least 3 months.
  • Histologically or cytologically confirmed diagnosis of NSCLC.
  • Locally advanced or metastatic NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
  • Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Adequate organ function.

Exclusion Criteria:

  • Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
  • Other malignancies within 3 years prior to randomization.
  • Known actionable genomic alterations.
  • Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
  • Previous treatment with docetaxel.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
  • History of myocarditis, cardiomyopathy, and malignant arrhythmia.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivonescimab and docetaxel
Drug: Ivonescimab, docetaxel
Patients will receive ivonescimab and docetaxel as an IV injection
Other Names:
  • AK112, docetaxel
Active Comparator: Placebo and docetaxel
Drug: Placebo, docetaxel
Patients will receive placebo and docetaxel as an IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: approximately 5 years
Overall Survival (OS) in the FAS population
approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: approximately 3 years
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
approximately 3 years
Adverse Event (AE)
Time Frame: From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first

Collaborators and Investigators

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

Sponsor

Akeso

Investigators

  • Principal Investigator: Caicun Zhou, Shanghai East Hospital

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)

July 8, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK112-305 (HARMONi-8A)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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