beta
Trial Radar AI
Clinical Trial NCT06928389 (NSCLC) for Non-Small Cell Lung Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer (NSCLC) Phase 3 536 Randomized Double-Blind

Not yet recruiting
Clinical Trial NCT06928389 (NSCLC) is designed to study Treatment for Non-Small Cell Lung Cancer. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on June 1, 2025 until the study accrues 536 participants. Led by Akeso, this study is expected to complete by June 1, 2030. The latest data from ClinicalTrials.gov was last updated on May 1, 2025.
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 ...Show More
Official Title

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

Conditions
Non-Small Cell Lung Cancer
Other Study IDs
  • NSCLC
  • AK112-305 (HARMONi-8A)
NCT ID Number
NCT06928389
Start Date (Actual)
2025-06
Last Update Posted
2025-05-01
Completion Date (Estimated)
2030-06
Enrollment (Estimated)
536
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIvonescimab and docetaxel
Ivonescimab, docetaxel
Patients will receive ivonescimab and docetaxel as an IV injection
Active ComparatorPlacebo and docetaxel
Placebo, docetaxel
Patients will receive placebo and docetaxel as an IV injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Survival (OS)
Overall Survival (OS) in the FAS population
approximately 5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression Free Survival (PFS)
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
approximately 3 years
Adverse Event (AE)
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Akeso logoAkeso92 active studies to explore
Study Central Contact
Contact: Wenting Li, 18116403289, [email protected]
No location data.