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LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT04027946 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-16

Study results available
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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.

Conditions

Interventions

DRUG

LMB-100

Participants will receive LMB-100 on days 1, 3 and 5 of a 21-day cycle for up to 2 cycles.

DRUG

pembrolizumab

Participants will receive pembrolizumab on day 1 of each subsequent 21-day cycle.

DIAGNOSTIC_TEST

Mesothelin Expression

Testing for mesothelin expression performed at screening

DIAGNOSTIC_TEST

TrueSight Oncology 500

Testing for ROS oncogene 1 (ROS1) gene, anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) variations performed at screening.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Azam Ghafoor, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2020-06-17
Completion
2023-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027946 on ClinicalTrials.gov