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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Lantern Pharma Inc.
Study ID
NCT05456256
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adenocarcinoma of Lung
  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LP-300 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LP-300 in Combination with Pemetrexed and Carboplatin
    LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
  • Active Comparator: Pemetrexed and Carboplatin (Standard of Care)
    Pemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Precision NextGen Oncology and Research CenterBeverly HillsCalifornia90212
Kamalesh Sankhala, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles Cancer NetworkFountain ValleyCalifornia92708
Elizabeth Brown
[email protected]
Eric Lee, MD (PRINCIPAL_INVESTIGATOR)
Cancer and Blood Specialists ClinicLos AlamitosCalifornia90720-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Taylor Branch
[email protected]
Joseph Treat, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75235
Adam Itani
[email protected]
214-645-1365
Jonathan Dowell, MD (PRINCIPAL_INVESTIGATOR)
Inova Fairfax HospitalFairfaxVirginia22031
Mahwish Bari
[email protected]
Janakiraman Subramanian, MD (PRINCIPAL_INVESTIGATOR)
Amin Benyounes, MD (SUB_INVESTIGATOR)
David Lee, MD (SUB_INVESTIGATOR)
Nagla Karim, MD (SUB_INVESTIGATOR)

Find similar trials in Beverly Hills, CA

By research site
Precision NextGen Oncology and Research Center· Beverly Hills, CALos Angeles Cancer Network· Fountain Valley, CACancer and Blood Specialists Clinic· Los Alamitos, CAFox Chase Cancer Center· Philadelphia, PAUT Southwestern Medical Center· Dallas, TXInova Fairfax Hospital· Fairfax, VA

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