PROTO-2024-002 ICF

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

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.

If you agree to participate in this study, you will be randomly assigned (like flipping a coin) to receive either OncoPlex-X or standard chemotherapy.

As with any medical treatment, there are risks involved in participating in this study.

There is no guarantee that you will benefit from participating in this study. However, possible benefits may include:

• Access to a new experimental treatment that may work better than current standard therapies
• Your cancer may shrink or stop growing
• You may live longer or have better quality of life
• Close monitoring and frequent medical care by the study team

Participating in this study is your choice. If you decide not to participate, other treatment options are available for your condition:

• Standard chemotherapy — FDA-approved chemotherapy drugs commonly used for advanced NSCLC
• Targeted therapy — if your tumor has certain genetic changes, targeted medications may be available
• Immunotherapy — medications that help your immune system fight cancer
• Palliative care — treatment focused on relieving symptoms and improving quality of life

You or your insurance company will NOT be charged for the study drug, study-related tests, or study visits.

You will receive compensation for your time: $50 per clinic visit, plus parking reimbursement up to $25 per visit. Total compensation may be up to $600 over the course of the study.

We will do our best to keep your personal information private and confidential. Your personal information may be disclosed if required by law.

• Your name will not be used in any reports or publications
• You will be identified only by a unique study number
• Study records will be stored securely with restricted access
• Electronic data will be encrypted and password-protected per 21 CFR Part 11

Your participation in this research study is completely voluntary. You have the right to choose not to participate or to withdraw at any time without penalty or loss of benefits.

Withdrawal from the study will not affect your regular medical care. If you decide to withdraw, please notify a member of the study team.

• Principal Investigator: Dr. Sarah Johnson, MD, PhD — Phone: (555) 123-4567 | Email: s.johnson@researchcenter.org
• 24-Hour Emergency: Study Coordinator Jane Smith, RN — (555) 123-4999
• IRB Office: Research Ethics Office — (555) 123-4800 — irb@researchcenter.org

By signing this consent form, you confirm that:

• You have read and understood this form
• All your questions have been answered to your satisfaction
• You understand that participation is voluntary and you may withdraw at any time
• You voluntarily agree to participate in this research study

Participant

• ___________________________ Printed Name of Participant
• ___________________________ Signature — Date

Person Obtaining Consent

• ___________________________ Printed Name
• ___________________________ Signature — Date