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

Akeso

Status and phase: Not yet enrolling; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Placebo, docetaxel; Drug: Ivonescimab, docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06928389

AK112-305 (HARMONi-8A)

Details and patient eligibility

About

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.

Enrollment: 536 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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536 participants in 2 patient groups

Ivonescimab and docetaxel

Experimental group

Treatment:

Drug: Ivonescimab, docetaxel

Placebo and docetaxel

Active Comparator group

Treatment:

Drug: Placebo, docetaxel