A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung

Boehringer Ingelheim

Status: Completed

Conditions: Squamous Non-small Cell Lung Cancer

Treatments: Drug: Second line (2L) afatinib; Drug: Second line chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT04552535

1200-0325

Details and patient eligibility

About

This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of squamous or mixed histology non-small cell lung cancer

• Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV)

  • First cycle of pembrolizumab received after 06/01/2018
  • Permanently discontinued 1L pembrolizumab treatment

• Initiated second-line treatment at least 3 months prior to the date of data collection, with either :

  • Afatinib
  • Any chemotherapy

• Age ≥ 18 years

Exclusion criteria

-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial

Trial design

200 participants in 2 patient groups

Second line (2L) afatinib

Description:

Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Treatment:

Drug: Second line (2L) afatinib

Second line (2L) chemotherapy

Description:

Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Treatment:

Drug: Second line chemotherapy