Clinical trial · Observational
Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
A Prospective Study Of Immune Signatures In Metastatic Non-Small Cell Lung Cancer (mNSCLC) Patients At Completion Of Immune Checkpoint Inhibitor Treatment Either As Monotherapy Or In Combination With Chemotherapy In The First Line Setting
- 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)
The purpose of this study is to examine the association between ctDNA/immune biomarkers and disease progression in patients who, at immunotherapy discontinuation, have completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor combination chemotherapy for mNSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and tissue samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Biomarkers and ctDNA data generated from patients with metastatic non-small cell lung carcinoma who have completed first line immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor treatment.
- interventionNames
- Other: Blood and tissue samples
Primary outcomes (1)
- measure
- Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion
- timeFrame
- 6 months after immune checkpoint inhibitor treatment completion
- description
- Disease progression status determined by the treating investigator per standard care
Secondary outcomes (3)
- measure
- Disease progression status for the purpose of assessing its correlation with circulating effector T cell anergy at 0 months after pembrolizumab treatment completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Informed consent and HIPAA authorization for release of personal health information signed by the subject. Note: Data from tumor samples, blood samples and radiographic scans prior to enrollment date may be used. 2. Age greater than or equal to18 years at the time of consent. 3. Patients with metastatic non-small cell lung carcinoma have completed first line who, at immunotherapy discontinuation, have completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor monotherapy or pembrolizumab combination chemotherapy in the first line setting. 4. Patients are allowed to continue maintenance chemotherapy. 5. Ability to understand and comply with study procedures for the entire length of the study. 6. Known PD-L1 prior to initiation of first-line treatment for NSCLC. Exclusion Criteria 1. Enrollment/collection of baseline sample earlier than 7 days prior to scheduled last dose of immune checkpoint inhibitor treatment or more than 30 days after last dose of immune checkpoint inhibitor treatment. 2. Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1). 3. Patients who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab). 4. Known pregnancy. 5. Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.
References
Publications (0)
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