TerminatedPhase 2

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

Stopped: Study was terminated due to slow accrual.

United States6 participantsStarted 2019-09-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the following criteria apply. * Male and female participants who are at least 18 years of age on the day of signing the informed consent will be enrolled in the study. * Subjects must have histologically confirmed diagnosis of non-squamous non-small cell lung cancer not amenable to potentially curative treatments (surgical resection, definitive radiation therapy or a combined modality approach) or targeted agents to actionable epidermal growth factor receptor (EGFR) mutations or Anaplastic lymphoma kinase (ALK) or ROS oncogene 1 (ROS1) gene rearrangement and excluding neuroendocrine tumors. Activating Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations are allowed. The diagnosis must be confirmed by the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). Mutation confirmation may be done by referring institutions or by one of the assays in the Protocol. * Have provided archival tumor tissue sample or newly obtained fresh core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. * Histologically confirmed 25% of tumor cells expressing mesothelin as determined by NCI Laboratory of Pathology. Determination can be made using archival tumor tissue or fresh biopsy. * Have measurable disease base…

What they're measuring

Proportion of Participants With Partial Response or Complete Response Reported With an 80% Confidence Interval

Timeframe: End of treatment, an average of 83 days.

Proportion of Participants With Partial Response or Complete Response Reported With an 95% Confidence Interval

Timeframe: End of treatment, an average of 83 days.

Trial details

NCT IDNCT04027946

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-06-17

Results submitted2023-05-24

View on ClinicalTrials.gov More Lung Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Participants With Partial Response or Complete Response Reported With an 80% Confidence Interval

Timeframe: End of treatment, an average of 83 days.

Proportion of Participants With Partial Response or Complete Response Reported With an 95% Confidence Interval

Timeframe: End of treatment, an average of 83 days.