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

Completed

• Conditions: Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer; Healthy

• Registration Number: NCT04187768
• Lead Sponsor: Indiana University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2022-06-13
• Study Completion: 2022-06-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in B regulatory cells (Bregs)	baseline and cycle 3	change in Bregs before and after treatment
Mean change in T regulatory cells (Tregs) before and after treatment	baseline and cycle 3	change in Tregs before and after treatment
Mean change in myeloid derived suppressive cells (MDSCs)	baseline and cycle 3	change in MDSCs before and after treatment

Secondary Outcome Measures

Name	Time	Method
Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs	baseline, cycle 3
Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs	baseline, cycle 3

Trial Locations

Locations (1)

Indiana University Melvin & Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States