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

Phase 3

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Ivonescimab, docetaxel; Drug: Placebo, docetaxel

• Registration Number: NCT06928389
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-15
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-06
• Primary Completion: 2027-05
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 536

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivonescimab and docetaxel	Ivonescimab, docetaxel	-
Placebo and docetaxel	Placebo, docetaxel	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	approximately 5 years	Overall Survival (OS) in the FAS population

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	approximately 3 years	Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
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	Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results