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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)

ConditionsNSCLCBrain Metastasases
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • AK112 Injection

    Drug

    AK112 injection plus chemotherapy was administered to all eligible patients

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: AK112 combined with chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

iPFS

iPFS was defined as the time from the date of initiation of firstline setting to the date of intracranial progression or death and was censored at the date of the last tumor assessment (when carried out)

Time frame
iPFS was defined as the time from the date of initiation of firstline setting to the date of intracranial progression or death and was censored at the date of the last tumor assessment (when carried out)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: