Clinical trial · Observational
Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
NCT03877250CI-TRIAL-00089736withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The primary objectives have not been met due to no patient enrollment therefore, the PI is requesting to close the study at this time.
Summary
Brief summary (as posted)
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy at Disease Progression | Diagnostic Test | — | UNRESOLVED |
| On-Treatment Biopsy | Diagnostic Test | — | UNRESOLVED |
| Peripheral Blood-Based Studies | Diagnostic Test | — | UNRESOLVED |
| Pre-Treatment Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non Small Cell Lung Cancer (NSCLC)
- description
- Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
- interventionNames
- Diagnostic Test: Pre-Treatment Biopsy
- Diagnostic Test: On-Treatment Biopsy
- Diagnostic Test: Biopsy at Disease Progression
- Diagnostic Test: Peripheral Blood-Based Studies
Primary outcomes (1)
- measure
- Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 \>/= 50%) * Intended treatment with a PD-(L)1 inhibitor * Age \>/= 18 years * Karnofsky Performance Status \>/= 70% and medically fit to undergo a biopsy procedure Exclusion Criteria: * Any medical condition or any sites of disease that would preclude a biopsy * Pregnant or breastfeeding women * Cognitively impairment affecting ability to understand and provide informed consent * Prior PD-(L)1 blockade treatment * Chemotherapy within 6 months prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.