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Immunotoxin

LMB-100 + Pembrolizumab for Lung Cancer

Phase 2
Waitlist Available
Led By Azam Ghafoor, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subjects must have received prior standard of care treatments for locally advanced or metastatic non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date treatment consent signed to date off study, approximately 48.7 months
Awards & highlights

Study Summary

This trial is studying a combination of two drugs, LMB-100 and pembrolizumab, as a possible treatment for non-small cell lung cancer.

Who is the study for?
Adults over 18 with non-squamous NSCLC that's resistant to standard treatments can join. They must have a good heart function, be able to perform daily activities, and have recovered from previous therapies. Participants need measurable disease and cannot have severe autoimmune diseases, active infections, or certain other health conditions.Check my eligibility
What is being tested?
The trial tests if LMB-100 followed by pembrolizumab shrinks tumors in advanced NSCLC patients. It involves initial hospital stays for LMB-100 injections and then regular pembrolizumab doses for up to two years, with lifelong follow-up via visits or communication.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, immune system complications like inflammation of organs (which may require steroids), potential infection risks due to lowered immunity, and possibly others not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have received standard treatments for advanced non-small cell lung cancer.
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It has been over 3 weeks since my last systemic treatment like chemotherapy.
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All side effects from my previous cancer treatments are mild, except for hair loss and some nerve pain.
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My lung cancer is non-squamous and cannot be treated with surgery or targeted drugs.
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I am 18 years or older and have given my consent to participate.
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I have given a sample of my tumor for testing, either from an old or a new biopsy.
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My tumor has been confirmed to express mesothelin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date treatment consent signed to date off study, approximately 48.7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and date treatment consent signed to date off study, approximately 48.7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Partial Response or Complete Response Reported With an 80% Confidence Interval
Proportion of Participants With Partial Response or Complete Response Reported With an 95% Confidence Interval
Secondary outcome measures
Number of Participants Who Are Treated Who Are Unable to Tolerate the Treatment Other Than Development of Adverse Events
Number of Participants With a Response
Overall Response (OR)
+4 more
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mesothelin Expressing Non-Small Cell Lung Cancer ParticipantsExperimental Treatment4 Interventions
LMB-100 + Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Mesothelin Expression
2019
Completed Phase 2
~60
LMB-100
2019
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,266 Total Patients Enrolled
Azam Ghafoor, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

LMB-100 (Immunotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT04027946 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Mesothelin Expressing Non-Small Cell Lung Cancer Participants
Non-Small Cell Lung Cancer Clinical Trial 2023: LMB-100 Highlights & Side Effects. Trial Name: NCT04027946 — Phase 2
LMB-100 (Immunotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04027946 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other Mesothelin Expression clinical trials that have been completed?

"Currently, there are 1,000 ongoing studies related to mesothelin expression. Of those, 122 are in phase 3. Although many of the trials for this treatment are located in Houston, Texas, there are 36,034 total locations running these studies."

Answered by AI

What are the primary benefits of Mesothelin Expression?

"Mesothelin Expression is a treatment for cancerous growths. It can also help treat other conditions such as melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Are there any more positions available for participants in this trial?

"This trial is not presently recruiting candidates at this time. The clinical trial was first posted on 9/11/2019 and was most recently updated on 10/4/2022. If you are exploring for other studies, there are currently 2981 studies actively admitting participants with adenocarcinoma of lung and 1000 studies for Mesothelin Expression actively recruiting patients."

Answered by AI

Does the FDA recognize Mesothelin Expression as a therapeutic target?

"While there is some evidence that suggests Mesothelin Expression is safe, as this is only a Phase 2 trial, there is currently no data supporting its efficacy."

Answered by AI

How many people can join this clinical study?

"Unfortunately, this specific study is not looking for new patients right now. However, there are 2981 other clinical trials involving adenocarcinoma of the lung and 1000 studies concerning Mesothelin Expression that are currently enrolling participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Azam Ghafoor 2019. "LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04027946.
~1 spots leftby Apr 2025
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