Ivonescimab plus docetaxel for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind Phase 3 trial comparing ivonescimab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic NSCLC who progressed on PD-(L)1 inhibitor–based therapy. Eligible participants have prior platinum chemotherapy, measurable disease by RECIST 1.1, ECOG performance status 0–1, and adequate organ function. Participants are randomized to receive ivonescimab or placebo in combination with standard docetaxel and are followed for efficacy and safety outcomes. The study is conducted across participating centers with blinded treatment assignment.

Why it matters

Who can join: the full rules

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's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Caicun Zhou — Shanghai East Hospital
• Study coordinator: Wenting Li
• Email: wenting01.li@akesobio.com
• Phone: 18116403289

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.