NCT07485179Active, not recruiting
Emulation of the KEYNOTE-042 (NCT02220894) Trial 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
- 770 (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
- NCT07485179
What you commit to
- Study type: Observational
- Planned participants: 770
- 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 prior chemotherapy administration for advanced/metastatic NSCLC
- 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
Other illness
- Patients with documented interstitial lung disease
Lab values
- Pembrolizumab group: patients with documented EGFR/ALK positivity
- Chemotherapy group: patients with documented EGFR/ALK positivity or missing/unknown EGFR/ALK status
Other
- Missing/unknown or PD-L1 \< 50%
- Patients with documented CNS metastases
Who the study is looking for
- 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%
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 · Does not accept healthy volunteers
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.