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

Indiana University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04187768

CTO-IUSCC-0701

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

29 participants in 2 patient groups

Healthy Group

Description:

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

NSCLC Group

Description:

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.