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RecruitingNCT06928389NSCLCUpdated Apr 9, 2026

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

A Phase 3 interventional study of Ivonescimab, docetaxel and Placebo, docetaxel in Non-Small Cell Lung Cancer, sponsored by Akeso. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Akeso · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
536
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Non-Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 536 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
536 participants (estimated)

Study arms

  • Experimental
    Ivonescimab and docetaxel

    Drug: Ivonescimab, docetaxel

  • Active comparator
    Placebo and docetaxel

    Drug: Placebo, docetaxel

Interventions

  • DrugIvonescimab, docetaxel

    Patients will receive ivonescimab and docetaxel as an IV injection

    Also known as: AK112, docetaxel

  • DrugPlacebo, docetaxel

    Patients will receive placebo and docetaxel as an IV injection

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Overall Survival (OS) in the FAS population

    Time frame: approximately 5 years

Secondary outcomes

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

    Time frame: approximately 3 years

  2. Adverse Event (AE)

    Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

    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

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Study locations

1 of 1 sites recruiting
  • Shanghai East Hospital
    Shanghai, Shanghai Municipality, China
    • Caicun Zhou · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06928389
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Jul 8, 2025
Primary completion
May 2027 (estimated)
Completion
Jun 2030 (estimated)
Last update
Apr 9, 2026

Study contacts

Wenting Li
Contact
wenting01.li@akesobio.com
18116403289
Caicun Zhou
principal investigator · Shanghai East Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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