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

Squamous Non-small Cell Lung Cancer Clinical Trial

Official title:

Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552535
• Other study ID #: 1200-0325
• Status: Completed
• Start date: May 8, 2020
• Est. completion date: May 18, 2020

Study information

• Verified date: December 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Lung Neoplasms
• Squamous Non-small Cell Lung Cancer

Intervention

Drug:
• Second line (2L) afatinib
Afatinib
• Second line chemotherapy
Chemotherapy

Locations

Country	Name	City	State
United States	Cardinal Health Specialty Solutions	Dublin	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
Primary	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.	From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
Primary	Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment	Chart abstractors (i.e. the patients treating physician) were asked to abstract information regarding severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during first line (1L) treatment and second line (2L) for both patients treated with afatinib in 2L and those treated with chemotherapy in 2L. Providers/abstractors were asked only if these specific immune related events occurred.	From the start of second-line treatment to the end of follow-up, up to 15 months

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