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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been diagnosed with Stage 3 or Stage 4 non-small cell
lung cancer?
Have you ever been a smoker?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will measure how safe and tolerable a drug is and test its effectiveness in treating advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have stopped responding to standard treatments or have no standard options left. They should be relatively healthy otherwise, with a life expectancy over 3 months and stable brain conditions if present. Pregnant or breastfeeding individuals, those with significant heart issues, recent major surgery, or active severe infections are excluded.Check my eligibility
What is being tested?
The study tests LP-184's safety and the maximum tolerated dose in patients with advanced solid tumors. It also looks at how the body processes LP-184 and its effectiveness against these cancers.See study design
What are the potential side effects?
While not specified here, potential side effects of LP-184 could include typical reactions to cancer drugs such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies, liver function alterations, and possibly unique effects related to this specific drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of AEs
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC) of LP-184 and major metabolite
Half-life of LP-184 [if data permits (T1/2)]
Maximum Plasma Concentration of LP-184 (Cmax)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184Experimental Treatment1 Intervention
Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184 in Patients with Advanced Solid Tumors
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Who is running the clinical trial?
Lantern Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
227 Total Patients Enrolled
Reggie Ewesuedo, MDStudy DirectorLantern Pharma Inc.
2 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment within the last 2 weeks or 4 weeks for biologics.My doctor suspects or has confirmed I have cancer spread to the lining of my brain and spinal cord.I am 18 years old or older.My side effects from previous treatments are mild or gone.My cancer has returned or didn’t respond to treatment, and there’s no standard treatment left.I can care for myself and perform normal activities.My liver, kidneys, bone marrow, and blood clotting are working well.You do not have any signs of cancer spreading to your brain.I have treated brain metastases and am on a stable low dose of dexamethasone.I've had brain treatment for new lesions found during a study screening MRI.It has been over 3 weeks since I had whole brain radiation therapy.I had stereotactic radiosurgery at least 7 days before starting LP-184.It has been more than 28 days since my surgery.I have not had major surgery in the last 4 weeks.I have not had radiation in the last 4 weeks.I have brain metastases but am not currently symptomatic or on steroids.I am on a stable dose of 2 mg or less daily of dexamethasone, approved by a medical professional.I don't need immediate treatment for any brain lesions.I have brain metastases that don't require immediate treatment.I have a heart condition that affects my health.My side effects from previous treatments are mild or have returned to normal, except for some long-term mild issues.I don't have untreated brain lesions larger than 2 cm, or I have approval for my condition.I have a history of eye diseases affecting my retina or macula.I am taking more than 2 mg of dexamethasone daily for brain cancer symptoms.I am currently suffering from a severe infection.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have any additional openings for participants?
"This medical trial, initially launched on June 9th 2021, is currently seeking participants as per information listed in clinicaltrials.gov. The latest update to the study was posted July 3rd 2021."
Answered by AI
Has the LP-184 trial successfully been granted federal approval?
"Our team has evaluated the safety of Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184 as a 1 due to there being only limited data indicating its efficacy and safety."
Answered by AI
What is the enrollment capacity for this trial?
"That is true. According to clinicaltrials.gov, this medical trial posted on June 9th 2023 still needs participants and was recently updated July 3rd 2023. 35 subjects are required from one centre for the study's completion."
Answered by AI
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