Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06928389
- Run by
- Akeso
- People needed
- 536
- Starts
- 2025-07-08
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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