Ivonescimab, docetaxel: Patients will receive ivonescimab and docetaxel as an IV injection
Placebo, docetaxel: Patients will receive placebo and docetaxel as an IV injection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival (OS) — approximately 5 years Overall Survival (OS) in the FAS population
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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