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

NCT ID: NCT04187768

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2022-06-13

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

Conditions

Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Healthy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Group

Healthy volunteers will donate a sample of blood to be used as controls

No interventions assigned to this group

NSCLC Group

Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy.

No interventions assigned to this group

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nasser Hanna

Professor of Medicine, Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasser Hanna, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Unversity

Locations

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CTO-IUSCC-0701

Identifier Type: -

Identifier Source: org_study_id