Clinical trial 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
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Non-small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment
timeFrame: 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
measure: Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status
timeFrame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
measure: Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status
timeFrame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
measure: Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment
timeFrame: From the start of second-line treatment to the end of follow-up, up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health Specialty Solutions
state: Ohio
Study officials:
References: