Actively Recruiting
A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
Led by Lantern Pharma Inc. · Updated on 2026-05-04
90
Participants Needed
16
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with inoperable advanced (Stage III or IV) primary adenocarcinoma of the lung with specific actionable genomic alterations confirmed by pathology
- Locally advanced inoperable or metastatic lung cancer
- Never smokers or those who smoked less than 100 cigarettes (or equivalent) in their lifetime
- Previous treatment with tyrosine kinase inhibitors for non-small cell lung cancer with disease progression or intolerance
- Prior radiation allowed if at least one measurable tumor area not previously irradiated and radiation effects resolved for at least 21 days
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least 18 years of age
- Stable central nervous system metastases without recent cognitive or motor deficits or seizures; off anti-seizure medications and steroids for at least 14 days
- Fully recovered from major surgery or staging procedures at least 30 days before enrollment
- Adequate bone marrow, liver, and kidney function based on specific laboratory values within 21 days prior to enrollment
- Female patients of childbearing potential must have negative pregnancy test and agree to use contraception during and 12 weeks after treatment; male patients with partners of childbearing potential must also use contraception
- Disease-free from other malignancies for at least 2 years, except certain treated non-invasive cancers
- Willing to provide a tumor tissue sample obtained less than 36 months ago from a non-irradiated tumor site
- Able to provide informed consent
You will not qualify if you...
- Diagnosis of small cell, squamous cell, large cell, undifferentiated, mesothelioma, or mixed lung cancers
- Metastatic adenocarcinoma from non-lung primary sites
- Prior investigational drugs except tyrosine kinase inhibitors, with required washout
- Disease progression on chemotherapy or immunotherapy prior to tyrosine kinase inhibitors
- Use of medications that interact with CYP2C19 or P-gp transporters
- Recent serious cardiac events or conditions within 6 months
- Corrected QT interval greater than 470 msec on ECG unless specific exceptions apply
- Unstable central nervous system metastases within 21 days
- No measurable disease site not previously irradiated
- Positive for HIV, hepatitis B surface antigen, or hepatitis C virus
- Active infections, interstitial lung disease, uncontrolled high blood pressure, diabetes, seizures, or other serious medical conditions
- Known allergies to study drugs or supportive agents
- Pregnancy or breastfeeding
- Blood transfusions within 10 days before enrollment
- Any other condition that may affect study adherence or result interpretation
- Life expectancy less than 3 months
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
2
Los Angeles Cancer Network
Fountain Valley, California, United States, 92708
Actively Recruiting
3
Cancer and Blood Specialists Clinic
Los Alamitos, California, United States, 90720
Suspended
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
5
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
6
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Active, Not Recruiting
8
Kanagawa Cancer Center Hospital
Yokohama, Kanagawa, Japan
Active, Not Recruiting
9
Tohoku University Hospital
Sendai, Miyagi, Japan
Active, Not Recruiting
10
Okayama University Hospital
Okayama, Okayama-ken, Japan
Active, Not Recruiting
11
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Active, Not Recruiting
12
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
Actively Recruiting
13
Chi Mei Medical Center
Tainan, Taiwan
Actively Recruiting
14
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
15
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
16
TriService General Hospital-Neihu Main Facility
Taipei, Taiwan
Actively Recruiting
Research Team
S
Sandra Sinclair
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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