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

• Status: Recruiting
• Trial end date: 2024-03-31

Summary

Background:

Over 230,000 new lung cancer cases are diagnosed every year in the U.S. About 80% of lung cancers are 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

• CT and PET scans: They will like 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.

• Phase: Phase 2

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Pembrolizumab