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

NCT07485166 | Active Not Recruiting FDA Drug

• 1 other identifier: 2022P002556-ENC-CheckMate1757
• Study Type: observational
• Target: 810
• 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 Non-squamous Non-small-cell Lung Cancer; Advanced Squamous Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  Hazard ratio (95% CI) for overall survival

  Through the earliest of outcome, censoring, or end of data (April 2024)

Study Arms (2)

Initiation of nivolumab

Exposure group

Drug: Initiation of nivolumab

Initiation of docetaxel

Reference group

Drug: Initiation of docetaxel

Interventions

Initiation of docetaxel DRUG

Initiation of docetaxel described in electronic health records is used as the reference.

Initiation of docetaxel

Initiation of nivolumab DRUG

Initiation of nivolumab described in electronic health records is used as the exposure.

Initiation of nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with NSCLC who present with advanced/metastatic (Stage IIIB/ Stage IV) disease and have experienced disease recurrence or progression during or after the prior platinum doublet-based chemotherapy regimen

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

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

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 8, 2026

Record last verified: 2026-02

Locations

US (1)