Emulation of the KEYNOTE-042 (NCT02220894) Trial Using Specialty Oncology Electronic Health Records Databases

Running, not enrolling

Conditions studied: Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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

NCT07485179

Run by

Brigham and Women's Hospital

People needed

770

Starts

2026-03-12

Expected to finish

2027-03-12

Last updated by the study team

2026-05-12

Who can join

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

You may qualify if…

• Age ≥18 years at treatment initiation
• Subjects with histologically or cytologically confirmed advanced or metastatic NSCLC that is not amenable to curative-intent treatment
• ECOG 0 or 1
• Line of therapy setting classified as "advanced" (EDB1) or "metastatic" (EDB2), or evidence of metastatic disease at treatment initiation (EDB4)
• PD-L1 ≥ 50%

You may not qualify if…

• Patients with documentation of prior chemotherapy administration for advanced/metastatic NSCLC
• Pembrolizumab group: patients with documented EGFR/ALK positivity
• Chemotherapy group: patients with documented EGFR/ALK positivity or missing/unknown EGFR/ALK status
• Missing/unknown or PD-L1 < 50%
• Patients with any documentation of an investigational agent within 4 weeks prior to initiation of first-line pembrolizumab/chemotherapy
• Squamous patients with any documentation of prior carboplatin plus paclitaxel
• Patients with any documentation of chemotherapy or biologic therapy within 3 weeks prior to initiation of first-line pembrolizumab/chemotherapy
• Patients with documentation of prior immunotherapy administration
• Patients with any prior non-lung malignancy diagnosis (exceptions: basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and in situ cervical cancer)
• Patients with documented autoimmune diseases within 2 years prior to treatment initiation
• Patients with documented interstitial lung disease
• Patients with documented CNS metastases

Where it is running

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

Full record on ClinicalTrials.gov

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