LP-300 for Never-smokers with NSCLC Adenocarcinoma
STAGE
Phase 2
DISEASE
Non-Small Cell Lung Cancer
TREATMENT
LP-300 + Carboplatin and Pemetrexed
The FDA has authorized the launch of our Phase 2 clinical trial (the “Harmonic™ Trial”) of LP-300 in combination with carboplatin and pemetrexed in never smoker patients with relapsed advanced primary adenocarcinoma of the lung after treatment with tyrosine kinase inhibitors. Our purpose in conducting the study is to determine the potential clinical advantages for this drug combination in the study-defined patient population.
The trial is designed as a multicenter, open label, Phase 2 trial with planned enrollment of approximately 90 patients. Patients who are never smokers with lung adenocarcinoma and have relapsed after prior treatment with tyrosine kinase inhibitors will be eligible for enrollment. Following a six-patient safety lead-in stage, the trial will consist of randomization in a 2:1 allocation ratio to one of two arms: Arm A (consisting of carboplatin, pemetrexed, and LP-300) or Arm B (consisting of carboplatin and pemetrexed).
For more information on the Harmonic™ clinical trial, please visit www.harmonictrial.com or the ClinicalTrials.gov study page.
