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

Sponsor
Akeso
Study ID
NCT06928389
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab, docetaxel — DRUG
    Patients will receive ivonescimab and docetaxel as an IV injection
  • Placebo, docetaxel — DRUG
    Patients will receive placebo and docetaxel as an IV injection

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2030

Study Design

Enrollment
536 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab and docetaxel
  • Active Comparator: Placebo and docetaxel

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: approximately 5 years ]

Central Contacts

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