Testing ivonescimab with docetaxel for advanced lung cancer after prior immunotherapy
Tests ivonescimab plus docetaxel against placebo plus docetaxel in adults with advanced lung cancer.
Key facts
- Who runs it
- Akeso
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 536 people, planned
- Started
- 8 Jul 2025
- Expected to end
- Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ivonescimab, docetaxel
- Placebo, docetaxel
- Record updated
- 9 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread non-small cell lung cancer that got worse after earlier chemotherapy and a PD-1/PD-L1 inhibitor.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Non-small cell lung cancer that is locally advanced or has spread (metastatic), with at least one lesion that can be measured.
- Earlier treatment
- Must have had platinum-based chemotherapy and PD-1/L1 inhibitors. Must not have had docetaxel before.
- Biomarker or test result
- Known actionable gene changes are not allowed.
Main reasons for not taking part
- Small cell lung cancer
- Other cancers within 3 years before randomization
- Known actionable gene changes
- Previous docetaxel treatment
- Active autoimmune disease needing systemic therapy within 2 years
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of severe bleeding tendency or coagulation dysfunction
- History of myocarditis, cardiomyopathy, and malignant arrhythmia
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
- Known actionable genomic alterations
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Shanghai East HospitalShanghai, ChinaContact: Caicun ZhouTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Ivonescimab and docetaxelTreatment being tested
Treatment: Ivonescimab, docetaxel
- Placebo and docetaxelExisting treatment, for comparison
Treatment: Placebo, docetaxel
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Testing ivonescimab with docetaxel for advanced lung cancer after prior immunotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06928389, who can take part
- Record updated
- 9 April 2026