Real-world post-authorization effectiveness study (PAES) of pembrolizumab for the treatment of NSCLC across races, ethnicities, and age groups (MK-3475-G18)

Study identification

• EU PAS number:
  EUPAS1000000576
• Study ID:
  1000000576
• Official title and acronym:
  Real-world post-authorization effectiveness study (PAES) of pembrolizumab for the treatment of NSCLC across races, ethnicities, and age groups (MK-3475-G18)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a real-world post-authorization effectiveness study (PAES) to characterize the real world effectiveness of pembrolizumab for the treatment of non-small cell lung cancer (NSCLC) among United States (US) patients across races, ethnicities, and age groups to address part of an FDA post-marketing commitment (PMC) for KEYNOTE-671 (4531-2). ; The primary objectives are as follows: ; (1) To evaluate the real-world effectiveness of pembrolizumab monotherapy in US NSCLC patients by estimating real-world overall survival (rwOS) among the following subgroups: Race (racial minorities [e.g., Black or African American, Asian, American Indian/Alaska Native, Native Hawaiian/Other Pacific Islander, and Other Race] and white patients), Hispanic/Latino ethnicity (Hispanic/Latino patients and not Hispanic/Latino patients), and Age (elderly patients ≥75 years and younger patients <75 years). ; (2) To evaluate the real-world effectiveness of pembrolizumab in combination with platinum-based chemotherapy in US NSCLC patients by estimating rwOS among the following subgroups: Race, Hispanic/Latino ethnicity, and Age.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

Flatiron Health, Inc.

Study timelines

Date when funding contract was signed

Planned:22/07/2024

Actual:22/07/2024

Study start date

Planned:04/01/2026

Actual:12/01/2026

Data analysis start date

Planned:31/12/2027

Date of final study report

Planned:15/11/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable