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

Completed

• Conditions: Squamous Non-small Cell Lung Cancer
• Interventions: Drug: Second line (2L) afatinib; Drug: Second line chemotherapy

• Registration Number: NCT04552535
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-08
• Primary Completion: 2020-05-18
• Study Completion: 2020-05-18
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-17
• Results First Submitted: 2021-05-17
• Results First Submitted QC: 2021-06-16
• Results First Posted: 2021-07-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status	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 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 on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status	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 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 on Treatment With Afatinib or Chemotherapy During Second Line (2L) 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	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.
Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment	From the start of second-line treatment to the end of follow-up, up to 15 months	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.

Trial Locations

Locations (1)

Cardinal Health Specialty Solutions; 🇺🇸 Dublin, Ohio, United States