The Harmonic™ clinical trial is enrolling participants in a Phase 2 multi-center study to evaluate an investigational new drug called LP-300. This trial is for never smoker patients with relapsed advanced primary adenocarcinoma of the lung, which is a type of non-small cell lung cancer (NSCLC).
The US Centers for Disease Control (CDC) defines a never smoker as an adult who has never smoked or has smoked less than 100 cigarettes in his or her lifetime. A never smoker can still develop NSCLC, which is clinically and genetically different from NSCLC in smokers. Harmonic™ is a clinical trial that is evaluating the overall and progression-free survival of never smoker patients with relapsed advanced NSCLC after treatment with the investigational new drug LP-300 in combination with chemotherapy.
Harmonic™ trial’s investigational new drug, LP-300, works together with chemotherapy by interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread. LP-300 has not been approved by the US Food and Drug Administration.
NSCLC presents differently in never smokers compared to smokers and is likely due to a higher percentage of genetic mutations in a family of cancer promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth.
You may be eligible for the trial if you are a never smoker but have NSCLC that has worsened despite taking a targeted therapy known as a TK inhibitor. You will not be eligible for the trial if you have taken chemotherapy or immunotherapy drugs. You can find out more information on eligibility requirements here.
You will be evaluated to see if you are eligible to participate in this study. A member of the research team will discuss the study details with you using what is called an informed consent form. After you have agreed to participate and signed the informed consent form, the research team will collect your medical history and do all the laboratory tests, tumor imaging scans, and exams that are necessary to determine your eligibility for study participation. The screening period can take up to 21 days.
If you are eligible to participate, you will be assigned to receive either LP-300 with carboplatin and pemetrexed chemotherapy or carboplatin and pemetrexed chemotherapy alone. The drugs will be given on Day 1 of a 21-day cycle for a total of 6 cycles. After you are finished with the 6 cycles, you will have the option to continue pemetrexed maintenance chemotherapy until your cancer progresses, you experience unacceptable side effects, or you and/or your physician decide that you should discontinue it.
Once you stop taking the investigational new drug, you will complete a site visit 14 days after the last dose to see how you are doing. You will then have follow-up visits every 9 weeks for the first year and every 3 months thereafter. During these follow-up visits, the research team will see if your cancer has progressed and update any changes to your medical history.
To learn more about taking part in the Harmonic™ trial, please fill out the form below :
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