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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

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ClinicalTrials.gov Identifier: NCT04552535
Recruitment Status : Completed
First Posted : September 17, 2020
Results First Posted : July 8, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment
Squamous Non-small Cell Lung Cancer Drug: Second line (2L) afatinib Drug: Second line chemotherapy

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : May 8, 2020
Actual Primary Completion Date : May 18, 2020
Actual Study Completion Date : May 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) 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 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.

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

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

  4. Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552535


Locations
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United States, Ohio
Cardinal Health Specialty Solutions
Dublin, Ohio, United States, 43017
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol and Statistical Analysis Plan  [PDF] September 20, 2019

More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04552535    
Other Study ID Numbers: 1200-0325
First Posted: September 17, 2020    Key Record Dates
Results First Posted: July 8, 2021
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action