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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 two chemotherapy drugs in patients with EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKI treatment.
Please contact your doctor
or email medinfo@smmttx.com for more information.
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, compared to placebo* combined with the same two chemotherapy drugs.
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.
- You need to be 18 years or older to enroll.
- Please talk with your doctor if you are interested to determine if you are eligible.
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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.
*Placebo is something given to a person that is not an active drug.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority.