NCT07485166Active, not recruiting
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 810 (estimated)
- First submitted
- 13 Mar 2026
- Start date
- 12 Mar 2026
- Primary completion date
- 12 Mar 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07485166
What you commit to
- Study type: Observational
- Planned participants: 810
- From 12 Mar 2026 to the primary completion date, 12 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Patients without documentation of disease progression between initiation of 1L platinum doublet-based chemotherapy and initiation of nivolumab or docetaxel
- Patients with documented autoimmune diseases within 2 years before/on treatment initiation
- Patients with documented interstitial lung disease before/on treatment initiation
- Patients with any other anti-cancer therapy during the treatment assessment window
Other
- Patients with documentation of docetaxel or nivolumab use before treatment initiation
- Patients with documented CNS metastases before/on treatment initiation
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.