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LP-300

Phase 3

Adenocarcinoma of Lung | Small Molecules | Oncology |Lantern Pharma Inc.|Trials Updated: May 4, 2026

LP-300 development status

Highest phase Phase 3 (NCT00039780)
Phase scored for LTRNPhase 2
Registered trials 2 across 2 sponsors since Jul 2022

LP-300 target and mechanism

ModalitySmall Molecules

Also known as Tavocept, BNP7787, Dimesna

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment854

FDA Designations

No designations recorded

LP-300 clinical trials

LP-300 · 2 trials · 5 indications

Phase 3 1Phase 2 1
NCT00039780Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly PaclitaxelBreast Neoplasms
COMPLETED764 Analytics
PHASE3COMPLETED
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate
baseline to disease progression or discontinuation from study
Progression-free survival (PFS)
Through study completion, an average of 2 years

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

Overall survival (OS)
Through study completion, an average of 2 years

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

Secondary Endpoints

Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity
baseline to end of treatment
Time-to-onset of clinically important neurotoxicity
randomization to date of first occurrence of clinically important neurotoxicity
Incidence of Neurosensory and Neuromotor Functional Impairment
baseline through end of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORTavocept (BNP7787)
2PLACEBO_COMPARATOR0.9% Sodium Chloride Soln.
LP-300 in Combination with Pemetrexed and CarboplatinEXPERIMENTALLP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Pemetrexed and Carboplatin (Standard of Care)ACTIVE_COMPARATORPemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.

Interventions

NameTypeDescription
BNP7787DRUGThe treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
PlaceboDRUGThe treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
LP-300DRUGLP-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.
PemetrexedDRUGPemetrexed: 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.
CarboplatinDRUGCarboplatin: 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

INCLUSION CRITERIA Histologically or cytologically documented metastatic breast cancer Measurable disease Performance Status; ECOG 0-2 More than 2 weeks since prior radiation therapy 14 days or more since prior therapy and recovered from all side effects For patients who progress while receivi...

Countries:United StatesJapanTaiwan
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Frequently asked questions about LP-300

What is LP-300 used for?

LP-300 is being developed for the treatment of advanced lung adenocarcinoma, specifically in never smokers with advanced lung adenocarcinoma and non-small-cell lung cancer. It is an investigational small molecule studied in combination with carboplatin and pemetrexed in patients with this biomarker-selected form of lung cancer.

Who is developing LP-300?

LP-300 is being developed by Lantern Pharma Inc., a biopharmaceutical company whose common stock trades under the ticker symbol LTRN. Lantern Pharma is the sponsor of the clinical program evaluating LP-300 in advanced lung adenocarcinoma.

What phase is LP-300 in?

LP-300 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study is currently recruiting participants and is designed to enroll approximately 90 patients across the United States, Japan, and Taiwan.

What clinical trials is LP-300 in?

LP-300 is being evaluated in the Phase 2 trial NCT05456256, titled A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma. The trial is actively recruiting, is randomized and active-controlled, and has an estimated enrollment of 90 participants aged 18 years and older.

How is the LP-300 trial designed?

The Phase 2 trial NCT05456256 is a randomized, active-controlled study evaluating LP-300 in combination with carboplatin and pemetrexed in never smokers with advanced lung adenocarcinoma. It is not double-blinded, enrolls approximately 90 patients, and is recruiting in the United States, Japan, and Taiwan.

Who can enroll in the LP-300 trial?

The Phase 2 trial NCT05456256 enrolls adults aged 18 years and older of any sex with advanced lung adenocarcinoma, specifically never smokers. The study is biomarker-selected and does not accept healthy volunteers. It is recruiting at sites in the United States, Japan, and Taiwan.