RecruitingPhase 2NCT05456256

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)

Sponsor

Lantern Pharma Inc.

Enrollment

90 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Adenocarcinoma of Lung

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called LP-300 combined with standard chemotherapy (carboplatin and pemetrexed) in people who have never smoked and have advanced lung adenocarcinoma (a type of non-small cell lung cancer) with specific genetic mutations. LP-300 may help overcome resistance to chemotherapy in this population. **You may be eligible if...** - You have inoperable advanced (stage III or IV) lung adenocarcinoma - You have never smoked, or have smoked fewer than 100 cigarettes in your lifetime - Your tumor has a known actionable genetic mutation (such as EGFR, ALK, MET, NTRK, or similar) - You have received prior targeted therapy but your cancer has progressed - Your organ function is adequate **You may NOT be eligible if...** - Your tumor has no known actionable genetic alteration - You are a current or significant former smoker - You have severe kidney, liver, or blood count problems - You are pregnant or breastfeeding - You have active brain metastases that are untreated or unstable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLP-300

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.

DRUGPemetrexed

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.

DRUGCarboplatin

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.

Locations(16)

Precision NextGen Oncology and Research Center

Beverly Hills, California, United States

Los Angeles Cancer Network

Fountain Valley, California, United States

Cancer and Blood Specialists Clinic

Los Alamitos, California, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Kanagawa Cancer Center Hospital

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

TriService General Hospital-Neihu Main Facility

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05456256

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