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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04027946
The ClinicalTrials.gov registry entry for NCT04027946 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which pembrolizumab is the first listed.
NCT04027946 reports 0 study locations.
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.
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