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PROTO-2024-002 ICFv1.0.pdf
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BIONOVATX INC. — CLINICAL RESEARCH

INFORMED CONSENT FORM

PROTO-2024-002 ICF

Protocol: PROTO-2024-002 · Version: v1.0 · Date: September 18, 2026

1. Introduction

You are being asked to take part in a research study. This form provides you with information about the study. A member of the research team will discuss this information with you and answer any questions you may have.

Your participation is voluntary. You may refuse to participate or discontinue your participation at any time without penalty or loss of benefits to which you are otherwise entitled. You will be given a copy of this form to keep.

  • Study Title: A Phase III Randomized Controlled Trial of OncoPlex-X in Advanced Non-Small Cell Lung Cancer
  • Principal Investigator: Dr. Sarah Johnson, MD, PhD
  • Sponsor: BioNovaTx Inc.
  • Protocol Number: PROTO-2024-001

2. Purpose of the Study

This research study is testing a new investigational drug called OncoPlex-X to see if it works better than current standard treatments for advanced non-small cell lung cancer (NSCLC). The main purposes of this study are to:

  • Find out if OncoPlex-X can help people with advanced NSCLC live longer
  • Determine if OncoPlex-X reduces tumor size more effectively than standard chemotherapy
  • Monitor and evaluate the safety of OncoPlex-X when given to people with advanced NSCLC
  • Understand how OncoPlex-X affects quality of life and disease symptoms

Approximately 600 patients from about 50 medical centers around the world will participate in this study.

PROTO-2024-002 · PROTO-2024-002 ICF · v1.0 · Page 1 of 12
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