Clinical trial · Observational
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
NCT07485166CI-TRIAL-00110898active not recruitingClinicalTrials.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)
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.
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 |
|---|---|---|---|
| Advanced Non-squamous Non-small-cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Squamous Non Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Initiation of docetaxel | Drug | — | UNRESOLVED |
| Initiation of nivolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Initiation of nivolumab
- description
- Exposure group
- interventionNames
- Drug: Initiation of nivolumab
- label
- Initiation of docetaxel
- description
- Reference group
- interventionNames
- Drug: Initiation of docetaxel
Primary outcomes (1)
- measure
- Overall survival [OS] - Time to all-cause mortality
- timeFrame
- Through the earliest of outcome, censoring, or end of data (April 2024)
- description
- Hazard ratio (95% CI) for overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Study Period: ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 2 (EDB2): Follow-up information through February 2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023. Inclusion Criteria: * Age ≥18 years at treatment initiation * Line-of-therapy setting is "advanced" (EDB1), "metastatic" (EDB2), or evidence of metastatic disease at treatment initiation (EDB4) * Subjects with NSCLC who present with advanced/metastatic (Stage IIIB/ Stage IV) disease and received treatment with nivolumab or docetaxel is 2L for advanced/metastatic diseases * ECOG 0 or 1 in the 90 days before/on treatment initiation Exclusion Criteria: * Patients without documentation of disease progression between initiation of 1L platinum doublet-based chemotherapy and initiation of nivolumab or docetaxel * Patients with documentation of docetaxel or nivolumab use before treatment initiation * Patients with documentation of immunotherapy use before treatment initiation * Patients with any prior non-lung malignancy diagnosis (except non-melanoma skin cancers and specified in situ cancers: bladder, gastric, colon, cervical/dysplasia, endometrial, melanoma, or breast) * Patients with documented autoimmune diseases within 2 years before/on treatment initiation * Patients with documented interstitial lung disease before/on treatment initiation * Patients with documented CNS metastases before/on treatment initiation * Patients with any other anti-cancer therapy during the treatment assessment window
References
Publications (0)
Data not yet available
No reference posted for this study.