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.
Eligibility
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.
