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NCT Number: NCT04187768

Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer

This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Healthy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Metastatic Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥ 18 years old at the time of informed consent
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Subjects with histologically and radiographically confirmed NSCLC.
  • Subjects must have stage IV disease or recurrent disease.
  • Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.
  • Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%.
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion criteria

  • Subjects with curable or potentially curable NSCLC.
  • Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.
  • Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.
  • Subjects eligible for combination treatment with chemoimmunotherapy.

Treatment and study plan

Primary outcomes

  1. Mean change in myeloid derived suppressive cells (MDSCs)

    Time frame: baseline and cycle 3

    change in MDSCs before and after treatment

  2. Mean change in B regulatory cells (Bregs)

    Time frame: baseline and cycle 3

    change in Bregs before and after treatment

  3. Mean change in T regulatory cells (Tregs) before and after treatment

    Time frame: baseline and cycle 3

    change in Tregs before and after treatment

Secondary outcomes

  1. Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs

    Time frame: baseline, cycle 3

  2. Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs

    Time frame: baseline, cycle 3

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2019
Registry last updated
Jul 20, 2022

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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