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)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

Qualifiers

The subjects voluntarily participated in the clinical study and had not received any systemic anti-tumor treatment (including any chemotherapy, targeted therapy, immunotherapy, etc.)

Male or female subjects aged 18-75 years (including the cutoff) at the time of signing the ICF

patients with histopathologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer (nsqNSCLC) with brain metastases

Patients were required to provide a genetic testing report that showed negative driver genes, i.e., no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion, no BRAF V600E sensitive gene mutation, and no RET gene fusion

Disqualifiers

None

Trial design

Treatments tested in this trial

  • AK112 Injection

Treatment groups

55 Participants
are divided into 1 treatment group

Sponsors and collaborators