HARMONi Phase 3 Clinical Trial

Are you or someone you love on osimertinib for advanced lung cancer?

If yes, there is a phase 3 clinical trial called HARMONi for patients with lung cancer who have an EGFR mutation and have progressed on osimertinib.

HARMONi is a randomized, double-blind, multi-center, phase 3 clinical trial of ivonescimab or placebo combined with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have progressed on EGFR-TKI treatment.

What is the purpose of this clinical trial?

• The purpose of this phase 3 clinical trial is to measure the safety and effectiveness of ivonescimab when combined with two chemotherapy drugs,* pemetrexed and carboplatin, compared to placebo** combined with pemetrexed and carboplatin.

What is the clinical trial drug, ivonescimab?

• Ivonescimab is an investigational bispecific antibody, which may simultaneously block two separate targets in the body; blocking these targets may decrease the cancer cells ability to live, grow, and spread.

Are you eligible for this clinical trial?

• You may be eligible if your lung cancer has an EGFR mutation and you have been treated with osimertinib.
• Please talk with your doctor if you are interested to determine if you are eligible.

If you are eligible, what is involved?
Your doctor can provide you with additional information but here are a few things to know:

• Once enrolled in the clinical trial, you will visit the clinic every three weeks for infusions that may continue up to 24 months.
• You will receive regular blood tests and scans of your tumor.
• You will be regularly asked about any side effects or safety concerns you have.

If you are in the clinical trial, will you receive ivonescimab?

• You will be randomly assigned to one of two treatment groups.
• Half the patients will be assigned to receive ivonescimab and chemotherapy, and the other half will receive placebo and chemotherapy.
• You will be given ivonescimab, chemotherapy, and placebo by infusion.

*Pemetrexed and carboplatin are a standard of care option for patients who have an EGFR mutation and have progressed on osimertinib (NCCN Guidelines 2023).
**Placebo is something given to a person that is not an active drug. 

Please contact your doctor for additional information.
Or email medinfo@smmttx.com

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.