BridgeMD
New treatment option for Adenocarcinoma of Lung
Official title A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
ClinicalTrials.gov ID: NCT05456256
What this study is testing
What is LP-300?
LP-300 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenocarcinoma of lung.
Also referred to as Tavocept, BNP7787.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with confirmed histopathological diagnosis of inoperable advanced (Stage III or IV) primary adenocarcinoma (including bronchioalveolar cell...
- 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...
- Patients who have received systemic treatment with tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer but have experienced disease...
- Prior radiation therapy is allowed, provided (1) that at least one area of measurable tumor (by computed tomography (CT) scan with at least one...
You likely can't join if
- Patients with small cell, squamous cell, large cell, undifferentiated, mesothelioma, or any form of mixed (e.g., small cell and adenocarcinoma or...
- 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...
- Patients who have received chemotherapy and/or immunotherapy but transitioned to a TKI with no evidence of disease progression will be allowed to...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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)...
- 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 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
- Aspartate aminotransferase/ serum glutamic oxaloacetic transaminase (AST/SGOT) ≤ 2.5 x ULN
- Alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Baseline serum creatinine level no greater than 1.5 mg/dL or 133 μmol/L.
- Creatinine clearance ≥ 45 mL/min as calculated using the Cockcroft-Gault methodology (Cockcroft 1976)
- Magnesium ≥ 1.7 mg/dL
- Female patients of child-bearing potential must have a negative pregnancy test and must agree to use an acceptable contraceptive method during the study and for 12 weeks after their last dose of study treatment. Male...
- Patients must have been disease-free at least two years for other malignancies, excluding:
- Curatively-treated basal cell carcinoma,
- Ductal carcinoma in situ (DCIS) of the breast
- Non-melanomatous carcinoma of the skin, or
- Carcinoma in situ of the cervix.
- Be willing to provide an archival tumor tissue sample, if available. The archival sample must be from a tumor lesion that was not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are...
- Provide signed, written, Institutional Review Board (IRB) approved informed consent prior to any screening procedures.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Patients who have a life expectancy of less than 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Fountain Valley, California, United States
- Los Alamitos, California, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Sapporo, Hokkaido, Japan
- Yokohama, Kanagawa, Japan
- Sendai, Miyagi, Japan
- Okayama, Okayama-ken, Japan
- Chuo-ku, Tokyo, Japan
- Hsinchu, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Fountain Valley, California, United States; Los Alamitos, California, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States; Fairfax, Virginia, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.