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.
Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs) will be eligible for enrollment. The trial will proceed in two stages. In the safety lead-in stage, 6 patients will be enrolled and treated with the LP-300 co-administered in combination with carboplatin and pemetrexed. In the absence of any safety signals in these patients, the second stage of the trial protocol will begin. This second stage consists of randomizing patients in a 2:1 allocation ratio to one of two arms: investigational arm of carboplatin, pemetrexed, and LP-300 or the standard of care arm of carboplatin and pemetrexed. Treatment of both groups will be on Day 1 of a 21-day cycle. A total of 4 to 6 treatment cycles are planned (number of cycles determined by PI discretion), with the possibility of patients going into a pemetrexed maintenance phase afterwards.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States
RECRUITINGLos Angeles Cancer Network
Fountain Valley, California, United States
RECRUITINGCancer and Blood Specialists Clinic
Los Alamitos, California, United States
RECRUITINGFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGInova Fairfax Hospital
Fairfax, Virginia, United States
RECRUITINGHokkaido Cancer Center
Sapporo, Hokkaido, Japan
RECRUITINGKanagawa Cancer Center Hospital
Yokohama, Kanagawa, Japan
RECRUITINGTohoku University Hospital
Sendai, Miyagi, Japan
RECRUITINGOkayama University Hospital
Okayama, Okayama-ken, Japan
RECRUITING...and 6 more locations
Progression-free survival (PFS)
Number of days or months from the date of randomization to the earliest of the documented disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
Number of days or months between the randomization date and the date of death from all causes
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
Proportion of patients with the best overall response of complete response or partial response
Time frame: Through study completion, an average of 2 years
Duration of objective response (DOR)
Time when the complete response/partial response criteria are met (whichever is first recorded) until the first date that recurrent or progressive disease is documented
Time frame: Through study completion, an average of 2 years
Clinical benefit rate (CBR)
Proportion of patients with the best overall response of complete response or partial response or stable disease for at least 120 days
Time frame: Through study completion, an average of 2 years
Safety of LP-300 in combination with pemetrexed and carboplatin
Incidence and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, and changes in clinical laboratory parameters, vital signs and electrocardiograms (ECGs).
Time frame: From initiation of study treatment to 30-days after the last dose of study drug.
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