Clinical trial · Observational
Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy
NCT04187768CI-TRIAL-00059761completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non Small Cell Lung Cancer Metastatic | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Healthy Group
- description
- Healthy volunteers will donate a sample of blood to be used as controls
- label
- 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.
Primary outcomes (3)
- measure
- Mean change in myeloid derived suppressive cells (MDSCs)
- timeFrame
- baseline and cycle 3
- description
- change in MDSCs before and after treatment
- measure
- Mean change in B regulatory cells (Bregs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.