Non-Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGIvonescimab, docetaxel
Patients will receive ivonescimab and docetaxel as an IV injection
DRUGPlacebo, docetaxel
Patients will receive placebo and docetaxel as an IV injection
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | approximately 5 years | Overall Survival (OS) in the FAS population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | approximately 3 years | Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1 |
| Adverse Event (AE) | 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 | Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results |
Countries
China
Contacts
CONTACTWenting Li
PRINCIPAL_INVESTIGATORCaicun Zhou
Shanghai East Hospital
Outcome results
None listed