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

NCT07485179 | Active Not Recruiting FDA Drug

• 1 other identifier: 2022P002556-ENC-KEYNOTE-042
• Study Type: observational
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Overall survival [OS] - Time to all-cause mortality (OS)

  Hazard ratio (95% CI) for overall survival

  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

Study Arms (2)

Initiation of pembrolizumab

Exposure group

Drug: Initiation of pembrolizumab

Initiation of chemotherapy

Reference group

Drug: Initiation of chemotherapy

Interventions

Initiation of pembrolizumab DRUG

Initiation of pembrolizumab (IV infusion) described in electronic health records is used as the exposure.

Initiation of pembrolizumab

Initiation of chemotherapy DRUG

Initiation of chemotherapy (carboplatin plus paclitaxel or pemetrexed for 4-6 cycles) described in electronic health records is used as the reference.

Initiation of chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with histologically or cytologically confirmed advanced or metastatic NSCLC that is not amenable to curative-intent treatment

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Somerville, Massachusetts, 02145, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): March 12, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-02

Locations

US (1)