Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Recruiting · NCT06928389 · Interventional (participants receive a specific treatment) · Lead sponsor: Akeso
View the official record on ClinicalTrials.gov →Interventions studied
Ivonescimab, docetaxelPlacebo, docetaxel
What this trial is 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Shanghai East Hospital - Shanghai, Shanghai Municipality, China