Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ivonescimab, docetaxel
- Placebo, docetaxel
Treatment groups
536 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov