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

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.

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 Overview

• Status: Completed
• Conditions: Squamous Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Second line (2L) afatinib; Drug: Second line chemotherapy

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Cardinal Health Specialty Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic Squamous cell carcinoma (SqCC) of the lung treated with pembrolizumab in combination with platinum doublet chemotherapy as first line (1L) treatment followed by either afatinib as second line (2L) treatment or chemotherapy as 2L treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Second line (2L) afatinib; Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))	Drug: Second line (2L) afatinib; Afatinib
Second line (2L) chemotherapy; Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))	Drug: Second line chemotherapy; Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 8, 2020
• Primary Completion (ACTUAL): May 18, 2020
• Study Completion (ACTUAL): May 18, 2020

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms, Squamous Cell; Lung Neoplasms; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: 1200-0325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No