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LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies)

Dosing occurs on Day 1 of a 21-day cycle.

Pemetrexed and Carboplatin Only (standard of care chemotherapies)

Dosing occurs on Day 1 of a 21-day cycle.

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.

LP-300

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.

Lyza Trejo

Mini Gill

Kamalesh Sankhala, MD

Monica King

Eric Lee, MD

Susan Tieng

Nihal Abdulla, MD

Sandy Tran

Robert Hsu

Celeste Barker

Patricia Rich

John Lewandowski

Taylor Branch

Joseph Treat, MD

Adam Itano

Jonathan Dowell, MD

Christine Terraciano

Kartik Konduri, MD

Mahwish Bari

Janakiraman Subramanian, MD

Amin Benyounes, MD

David Lee, MD

Nagla Karim, MD

Reggie Ewesuedo, MD

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.

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

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)

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

Number of days or months between the randomization date and the date of death from all causes

Proportion of patients with the best overall response of complete response or partial response

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

Proportion of patients with the best overall response of complete response or partial response or stable disease for at least 120 days

Lantern Pharma Inc.

Spots Global Cancer Trial Database for non smoker

Every month we try and update this database with for non smoker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for non smoker

Every month we try and update this database with for non smoker cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for non smoker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.