At a glance
ClinicalIndex Comparison Record- ✓Confirmed histopathological diagnosis of inoperable advanced (Stage III or IV) adenocarcinoma of the lung with specific actionable genomic alterations
- ✓No known actionable genomic alterations renders patient ineligible
- ✓Never smoker or smoked less than 100 cigarettes lifetime
- ✓Prior TKI treatment with disease progression, unacceptable toxicity, or intolerance
- ✕Small cell, squamous cell, large cell, undifferentiated, mesothelioma, or mixed histology
- ✕Metastatic adenocarcinoma from non-lung primary sites
- ✕Prior investigational agents except investigational TKI drugs
- ✕Disease progression on prior chemotherapy or immunotherapy excludes enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II 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 (The HARMONIC Study)
In Brief
A Phase 2 clinical trial evaluating LP-300, Pemetrexed, and 1 other intervention for Adenocarcinoma of Lung and Carcinoma, Non-Small-Cell Lung. Currently recruiting, targeting 90 participants across 16 sites in 3 countries.
Detailed Summary
The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.
Study Details
Timeline
Interventions
LP-300: 18.4 g/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.
Pemetrexed: 500 mg/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. After completion of the 4 to 6 cycles, patients will have the option to continue pemetrexed maintenance therapy until disease progression, unacceptable toxicity, or patient preference/physician discretion. The number of treatment cycles will be determined by PI discretion.
Carboplatin: area under the concentration-time curve 5 mg/mL per minute (AUC5) by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.