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NCT Number: NCT07075627

A Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)

This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. Screening and/or medical record review for symptoms associated with Lambert Eaton Myasthenic Syndrome (LEMS) will be conducted.

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Key information

About this study

This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. All eligible subjects enrolled will undergo a brief, symptom directed neurological evaluation and VGCC antibody testing (to be performed at a participating Quest laboratory). The results (positive/negative) of VGCC antibody testing will be documented as well as the receptor type P, Q or N.

These tests will be repeated quarterly (Q3 months) for the duration of the study.

If at any visit the subject is found to be BOTH neurologically suggestive of having LEMS and the VGCC Ab test is positive, then the subject is considered to be Clinically Suspicious of having LEMS. At any visit if a subject meets the criteria of Clinically Suspicious of LEMS. the end of study visit will be completed. Once the End of study visit is completed no further treatment information will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult men or women meeting Age of Majority (AOM) at the time of consent
  • Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)
  • Any diagnosis of SCLC
  • Willing to provide clinical and medical information related to his/her cancer diagnoses to the study team as required
  • Willing to comply with the requirements of the study

Exclusion criteria

  • Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome (LEMS) > 1 year prior to the SCLC diagnosis.
  • Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements

Treatment and study plan

Primary outcomes

  1. Suspicious LEMS

    Time frame: 1 year

    Incidence of clinically suspicious LEMS diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Allison M Harper, PharmD

CONTACT

[email protected]

704-996-6579

Sponsors and collaborators

Lead sponsor

Addario Lung Cancer Medical Institute

Other

Registry information

Official study title

An Observational Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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