NCT04552535 - 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 | Crick

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Squamous Non-small Cell Lung Cancer

Interventions

Second line (2L) afatinibDRUG

Afatinib

Second line chemotherapyDRUG

Chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardinal Health Specialty Solutions

Dublin, Ohio, United States

Outcomes

Primary Outcomes

Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment

Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment.

Time frame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated and up to 7.5 months for chemotherapy treated patients

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status

Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. Patients treated with afatinib were analysed for their histology status and categorized into a squamous cell - or mixed histology treatment group.

Time frame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status

Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment.