Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivonescimab, docetaxel, Placebo, docetaxel.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Ivonescimab, docetaxel
Patients will receive ivonescimab and docetaxel as an IV injection - Drug Placebo, docetaxel
Patients will receive placebo and docetaxel as an IV injection
Primary outcome measures
- Overall Survival (OS) [Time frame: approximately 5 years]
Secondary outcome measures (2)
- Progression Free Survival (PFS) [Time frame: approximately 3 years]
- Adverse Event (AE) [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai East Hospital — Shanghai
Identifiers
NCT: NCT06928389 · AK112-305 (HARMONi-8A)