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

NCT05456256 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LTRN300-2LC01-OR21
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 16

Brief 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.

Conditions

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

Keywords

never smoker; non smoker; EGFR; ALK; ROS; MET; tyrosine kinase inhibitor; TKI; pemetrexed; carboplatin; NSCLC; never-smoker; non-smoker; TK inhibitor; lung cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  Through study completion, an average of 2 years

• Duration of objective response (DOR)

  Through study completion, an average of 2 years

• Clinical benefit rate (CBR)

  Through study completion, an average of 2 years

• Safety of LP-300 in combination with pemetrexed and carboplatin

  From initiation of study treatment to 30-days after the last dose of study drug.

Study Arms (2)

LP-300 in Combination with Pemetrexed and Carboplatin

EXPERIMENTAL

LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.

Drug: LP-300; Drug: Pemetrexed; Drug: Carboplatin

Pemetrexed and Carboplatin (Standard of Care)

ACTIVE COMPARATOR

Pemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.

Drug: Pemetrexed; Drug: Carboplatin

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.

Also known as: Tavocept, BNP7787, Dimesna

LP-300 in Combination with Pemetrexed and Carboplatin

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.

Also known as: Alimta, Pemfexy

LP-300 in Combination with Pemetrexed and Carboplatin; Pemetrexed and Carboplatin (Standard of Care)

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.

Also known as: Paraplatin

LP-300 in Combination with Pemetrexed and Carboplatin; Pemetrexed and Carboplatin (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed histopathological diagnosis of inoperable advanced (Stage III or IV) primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung with specific actionable genomic alterations (e.g., mesenchymal epithelial transition (MET) exon14 skipping mutations, anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), neurotrophic tyrosine receptor kinase (NTRK) fusions, etc.). If pathological or radiological findings are inconclusive for a diagnosis of primary adenocarcinoma of the lung, additional studies must be performed to confirm primary lung versus metastatic adenocarcinoma. Patients with no known actionable genomic alterations are ineligible to enroll in the study.
• Locally advanced inoperable or metastatic lung cancer.
• Patients must be never smokers: a never smoker is an adult who has never smoked, or who has smoked less than 100 cigarettes (or equivalent in other products such as vapes, cigars, pipes, hookahs, and marijuana use) in his or her lifetime. Note: a patient with actionable genomic alteration(s) who is a former smoker may be enrolled if such a patient would ordinarily be treated with pemetrexed and carboplatin combination based on institutional standard clinical practice; consultation with the sponsor's Medical monitor would be required
• Patients who have received systemic treatment with tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer but have experienced disease progression, unacceptable TKI-related toxicities, or are unable to tolerate the further use of TKIs.
• Prior radiation therapy is allowed, provided (1) that at least one area of measurable tumor (by computed tomography (CT) scan with at least one target lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 that has not been subject to prior irradiation, and (2) that any such therapy is completed and any radiation-induced sequelae are recovered at least 21 days before randomization.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients who are at least 18 years of age.
• Patients with documented stable central nervous system (CNS) metastases with no cognitive deficits, or progressive sensory or motor deficits, or seizures during the last 21 days prior to enrollment are eligible. Patients must have discontinued anti-seizure medications and steroids at least 14 days prior to patient enrollment.
• Patients must have fully recovered from any prior major surgical or diagnostic staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative status of at least 30 days before enrollment.
• Patients must have adequate bone marrow, adequate hepatic function, and baseline creatinine levels documented by specific laboratory criteria within 21 days prior to enrollment, including the following:
• White blood cell count ≥ 2 x 10\*9/L
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\*9/L
• Hemoglobin ≥ 10 g/dL
• Platelet count ≥ 100 x 10\*9/L
• Total bilirubin \< 1.5 x the upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \< 2.5 x ULN

You may not qualify if:

• Patients with small cell, squamous cell, large cell, undifferentiated, mesothelioma, or any form of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological diagnosis of primary lung cancer.
• Patients with metastatic adenocarcinoma arising from any primary site other than the lung.
• Patients who have received any prior investigational agents except for investigational TKI drugs. The minimum drug washout period for all TKIs, including approved and investigational, is ≥ 5 half-lives or 2 weeks, whichever is shorter.
• Patients who have received chemotherapy and/or immunotherapy but transitioned to a TKI with no evidence of disease progression will be allowed to enroll. Patients who experienced disease progression while on chemotherapy and/or immunotherapy will be ineligible for the trial.
• Patients taking medications that are sensitive substrates of CYP2C19 or P-gp transporters
• Patients with recent onset (within 6 months of randomization) of congestive heart failure (New York Heart Association Classification Class II or greater), angina pectoris, unstable angina pectoris, serious uncontrolled cardiac arrhythmias, myocardial infarction, stroke, or transient ischemic attacks.
• Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec. (average of triplicate ECGs) at Screening and/or on C1D1 (pre- dose) except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment.
• Patients with unstable CNS metastases (characterized by progressive sensory/motor impairment, cognitive/speech impairment, or seizure activity) within 21 days before enrollment.
• Patients who do not have at least one (1) measurable disease site that has not been previously irradiated.
• Patients who are known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HbsAg) or hepatitis C virus (HCV).
• Patients with active infections, active interstitial lung disease, uncontrolled high blood pressure, uncontrolled diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the last 3 months, or other serious underlying medical condition.
• Patients with documented hypersensitivity to any of the study medications (LP-300, pemetrexed, carboplatin and/or excipients) or supportive agents that may be used.
• Patients who are pregnant or are breastfeeding.
• Patients who have undergone blood transfusions within 10 days before randomization.
• Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.

Sponsors & Collaborators

• Lantern Pharma Inc.: lead

Study Sites (16)

Precision NextGen Oncology and Research Center

Beverly Hills, California, 90212, United States

RECRUITING

Los Angeles Cancer Network

Fountain Valley, California, 92708, United States

RECRUITING

Cancer and Blood Specialists Clinic

Los Alamitos, California, 90720, United States

SUSPENDED

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Inova Fairfax Hospital

Fairfax, Virginia, 22031, United States

RECRUITING

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

ACTIVE NOT RECRUITING

Kanagawa Cancer Center Hospital

Yokohama, Kanagawa, Japan

ACTIVE NOT RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

ACTIVE NOT RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, Japan

ACTIVE NOT RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

ACTIVE NOT RECRUITING

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

TriService General Hospital-Neihu Main Facility

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

2,2'-dithiodiethanesulfonic acid; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Reggie Ewesuedo, MD

  Lantern Pharma Inc.

  STUDY DIRECTOR

Central Study Contacts

Sandra Sinclair

CONTACT

832.622.1699; sandra@lanternpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 13, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5); JP (5); US (6)