Study of PLB1004 for Non-Small Cell Lung Cancer with EGFR Mutations

This study is testing a new oral medication called PLB1004 for people with non-small cell lung cancer (NSCLC). This medication is for those whose cancer has specific changes (mutations) in a gene called EGFR. Researchers want to understand how safe PLB1004 is and how your body handles it. To join, you must be at least 18 years old, have recovered from previous cancer treatments or major surgery, and have a confirmed EGFR mutation in your cancer. The study is currently enrolling patients, with a plan for 81 participants in total. The main goal is to track any side effects of PLB1004 for up to two years.

Study design
This is a Phase 1, multi-center study where both you and your doctors will know which treatment you are receiving (open-label). It will involve a small number of participants, ranging from 21 to 42 in the first part, to find the best dose.
What's involved
You will take PLB1004 by mouth as the only treatment. The study will involve different groups (cohorts) to find the right dose.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to two years after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06046495

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avistone Biotechnology Co., Ltd.
~81 participants
Updated 2025-04-23 on ClinicalTrials.gov
What's tested:PLB1004

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety profile of PLB1004 per CTCAE v5.0
Measured over Up to 2 years
Non-Small Cell Lung Cancer
7 sites across 6 states
Washington2
California1
Kentucky1
Nebraska1
New York1
Tennessee1
Avistone Clinical Study Information Center Center
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  • Safety profile of PLB1004 per CTCAE v5.0Up to 2 years