Clinical trial · Observational
Emulation of the KEYNOTE-042 (NCT02220894) Trial Using Specialty Oncology Electronic Health Records Databases
NCT07485179CI-TRIAL-00111193active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Initiation of chemotherapy | Drug | — | UNRESOLVED |
| Initiation of pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Initiation of pembrolizumab
- description
- Exposure group
- interventionNames
- Drug: Initiation of pembrolizumab
- label
- Initiation of chemotherapy
- description
- Reference group
- interventionNames
- Drug: Initiation of chemotherapy
Primary outcomes (1)
- measure
- Overall survival [OS] - Time to all-cause mortality (OS)
- timeFrame
- Time from the end of the treatment assessment window defined by the vendor's business rules to identify the line of therapy until the earliest of outcome, censoring, or end of data availability
- description
- Hazard ratio (95% CI) for overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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% Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.