NCT06928389

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
50mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2025Jun 2030

First Submitted

Initial submission to the registry

April 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

April 8, 2025

Last Update Submit

April 7, 2026

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Overall Survival (OS) in the FAS population

    approximately 5 years

Secondary Outcomes (2)

  • Progression Free Survival (PFS)

    approximately 3 years

  • Adverse Event (AE)

    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

Study Arms (2)

Ivonescimab and docetaxel

EXPERIMENTAL
Drug: Ivonescimab, docetaxel

Placebo and docetaxel

ACTIVE COMPARATOR
Drug: Placebo, docetaxel

Interventions

Ivonescimab, docetaxelDRUG

Patients will receive ivonescimab and docetaxel as an IV injection

Also known as: AK112, docetaxel
Ivonescimab and docetaxel
Placebo, docetaxelDRUG

Patients will receive placebo and docetaxel as an IV injection

Placebo and docetaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Caicun Zhou

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenting Li

CONTACT

18116403289wenting01.li@akesobio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 15, 2025

Study Start

July 8, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2030

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

CN(1)