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NCT04027946 · ClinicalTrials.gov registry record · Phase 2
LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04027946: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04027946 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04027946, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: Over 230,000 new lung cancer cases are diagnosed every year in the United States (U.S.) About 80% of lung cancers are non- small cell lung cancer (NSCLC). Most people have a more advanced stage of the disease that doesn't respond well to standard treatment. Researchers want to see if a combination of drugs may be able to help. Objective: To find out if LMB-100 followed by pembrolizumab can help tumors to shrink in people with NSCLC. Eligibility: People ages 18 and older with NSCLC that has not responded to standard therapies Design: Participants will be screened with: * Medical history * Physical exam * Tumor sample. If one is not available, they will have a biopsy. * Assessments of ability to perform normal activities * Lung function tests * Blood, heart, and urine tests * Computed tomography (CT) and positron emission tomography (PET). They will lie in a machine that takes pictures of the body. Participants will take LMB-100 in 21-day cycles for up to 2 cycles. They will take the drug by injection into an arm vein on days 1, 3, and 5 of each cycle. They will stay in the hospital 7-10 days each cycle. Then they will get pembrolizumab by injection into an arm vein every 3 weeks for up to 2 years. They may be able to take pembrolizumab an additional year if their cancer gets worse. Participants will have repeats of the screening tests throughout the study. About 30 days and 90 days after they stop treatment, participants will have follow-up visits. Then they will have visits every 6-12 weeks. They will be followed for the rest of their life through phone calls and emails.
Primary Outcome
Participants with a partial response or complete response is reported with an 80% confidence interval. Response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Interventions
- DRUG pembrolizumab
- DRUG LMB-100
- DIAGNOSTIC_TEST Mesothelin Expression
- DIAGNOSTIC_TEST TrueSight Oncology 500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-09-11 |
| Est. Completion | 2023-12-22 |
| Phase | Phase 2 |
Why NCT04027946 stopped before completion
NCT04027946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which pembrolizumab is the first listed.
NCT04027946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04027946 about?
NCT04027946 is a clinical study titled "LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)". Background: Over 230,000 new lung cancer cases are diagnosed every year in the United States (U.S.) About 80% of lung cancers are non- small cell lung cancer (NSCLC). Most people have a more advanced stage of the disease that doesn't respond well to standard treatment. Researchers want to see if a ...
What is the current status of trial NCT04027946?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-09-11. Estimated completion is 2023-12-22.
What interventions are being tested in trial NCT04027946?
The interventions under investigation include: pembrolizumab (DRUG), LMB-100 (DRUG), Mesothelin Expression (DIAGNOSTIC_TEST), TrueSight Oncology 500 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04027946?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04027946's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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