NCT06684873

A Multicenter, Single-arm, Open-label Study Evaluating the Safety and Efficacy of AK112 Combined With Chemotherapy as First-line Treatment for Non-squamous NSCLC Patients With BRAIN Metastases and Negative Driver Genes (IVO BRAIN)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A multicenter, single-arm, open-label study evaluating the safety and efficacy of AK112 combined with chemotherapy as first-line treatment for non-squamous NSCLC patients with BRAIN metastases and negative driver genes

Detailed description

This is a multicenter, single-arm, open-label study. We planned to enroll 55 patients with histopathologically or cytologically confirmed stage IV nsqNSCLC with brain metastases and negative driver gene reports within three months. The aim of this study is to evaluate the safety, tolerability and efficacy of ivoricizumab combined with chemotherapy as the first-line treatment for patients with brain metastases from NSQ non-small cell lung cancer (NSCLC) without driver genes. Eligible subjects were selected and entered the study in sequence. The trial was divided into combination chemotherapy period (C1-C4/C6) and maintenance treatment period (C5/C7-C32). During the combined chemotherapy period, all subjects were treated with everciximab injection and chemotherapy drugs after entering the study, and during the maintenance treatment period, they were treated with everciximab injection and pemetrexed. Every 3 weeks (Q3W) was a treatment cycle. The efficacy was evaluated every 2 cycles in the combined chemotherapy period and every 3 cycles in the maintenance treatment period. All the participants received treatment until they withdrew consent, had disease progression, had unacceptable toxicity, had to discontinue the drug as judged by the investigator, were lost to follow-up, died, or had received ivorximab for 2 years, whichever occurred first. After the end of treatment, the patients were followed up until death. If there are abnormal items, for the safety of subjects, researchers can judge whether to add unplanned follow-up according to the actual situation.

Conditions

• NSCLC
• Brain Metastasases

Interventions

Type	Name	Description
DRUG	AK112 Injection	AK112 injection plus chemotherapy was administered to all eligible patients

Timeline

• Start date: 2024-11-02
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China