Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
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.
Checked against the public recordLast updated May 8, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Brigham and Women's Hospital
- Interventions being studied
- Drug: Initiation of nivolumab; Drug: Initiation of docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Brigham and Women's HospitalSomerville, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 8, 2026. Always confirm current availability with the study team.