Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology … (NCT07485166) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
United States810 participantsStarted 2026-03-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 bef…
What they're measuring
1
Overall survival [OS] - Time to all-cause mortality
Timeframe: Through the earliest of outcome, censoring, or end of data (April 2024)