Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics
About this trial
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
Eligibility criteria
Qualifiers
Age ≥ 18 years old at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Expected life expectancy ≥ 3 months
Metastatic (Stage IV) NSCLC
Disqualifiers
Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.
For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
Has received any prior therapy for NSCLC in the metastatic setting
Trial design
Treatments tested in this trial
- Ivonescimab Injection
- Pembrolizumab Injection
Treatment groups
1,600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov