Clinical trial · Observational
Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy
NCT04676386CI-TRIAL-00073594BEACON-LUNGterminatedClinicalTrials.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): Recruitment futility
Summary
Brief summary (as posted)
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) \> 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Stage IIIC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Immune Response (PIR) test by Biodesix, Inc. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PD1/PD-L1
- description
- Standard of Care: PD1/PD-L1 monotherapy
- interventionNames
- Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.
- label
- PD1/PD-L1 + chemo
- description
- Standard of Care: Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination
- interventionNames
- Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.
Primary outcomes (1)
- measure
- Biomarker PIR evaluation
- timeFrame
- 3 years
- description
- To collect biospecimens and evaluate candidate biomarkers of early progression on patients with \>50% PD-L1 positive tumors treated with PD-1/PD-L1 monotherapy or PD-1/PD-L1/chemotherapy combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS \> 50% * Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin * ECOG PS 0-2 * Ability to consent to participate in the study Exclusion Criteria: * Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
References
Publications (0)
Data not yet available
No reference posted for this study.