LP-300 + Chemotherapy for Lung Adenocarcinoma EGFR
(HARMONIC Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new drug, LP-300, combined with two existing chemotherapy drugs in never smokers with a specific type of lung cancer who did not respond to previous treatments. The goal is to see if this combination improves survival by making the chemotherapy more effective.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but it does mention a 'washout period' for tyrosine kinase inhibitors (TKIs) of at least 5 half-lives or 2 weeks, whichever is shorter. Also, you cannot take medications that are sensitive substrates of CYP2C19 or P-gp transporters.
What data supports the effectiveness of the drug combination LP-300, Carboplatin, and Pemetrexed for lung adenocarcinoma?
Is the combination of LP-300 and chemotherapy safe for humans?
What makes the LP-300 + Chemotherapy drug unique for lung adenocarcinoma?
The LP-300 + Chemotherapy treatment is unique because it combines LP-300, a novel agent, with carboplatin and pemetrexed, which are standard chemotherapy drugs. LP-300 is designed to enhance the effectiveness of chemotherapy by potentially reducing toxicity and improving outcomes, offering a new approach compared to traditional chemotherapy regimens.810111213
Research Team
Reggie Ewesuedo, MD
Principal Investigator
Lantern Pharma Inc.
Eligibility Criteria
This trial is for never smokers over 18 with advanced lung adenocarcinoma, including those who've had TKI treatment but now show disease progression or can't tolerate TKIs. Participants must have stable CNS metastases, adequate organ function, and no recent serious cardiovascular events. They should not be HIV or hepatitis positive and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
6 patients are enrolled and treated with LP-300 in combination with carboplatin and pemetrexed to assess safety
Treatment
Patients are randomized to receive either the investigational arm of LP-300 with carboplatin and pemetrexed or the standard of care arm of carboplatin and pemetrexed. Treatment occurs on Day 1 of a 21-day cycle for 4 to 6 cycles.
Maintenance
Patients may enter a pemetrexed maintenance phase after the initial treatment cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- LP-300
- Pemetrexed
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lantern Pharma Inc.
Lead Sponsor