NCT06928389RecruitingPhase 3
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab 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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 536 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 8 Jul 2025
- Primary completion date
- May 2027
- Lead sponsor
- Akeso
- Diseases
- Lung cancer
- NCT number
- NCT06928389
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 536
- From 8 Jul 2025 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancies within 3 years prior to randomization.
- Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- Previous treatment with docetaxel.
- Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
Other illness
- History of severe bleeding tendency or coagulation dysfunction.
- History of myocarditis, cardiomyopathy, and malignant arrhythmia.
Other
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
- Known actionable genomic alterations.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.