Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases

Running, not enrolling

Conditions studied: Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07485166

Run by

Brigham and Women's Hospital

People needed

810

Starts

2026-03-12

Expected to finish

2027-03-12

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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