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

NCT04552535 | Completed Results

• 1 other identifier: 1200-0325
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

Second line (2L) afatinib DRUG

Afatinib

Second line (2L) afatinib

Second line chemotherapy DRUG

Chemotherapy

Second line (2L) chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Cardinal Health Specialty Solutions

Dublin, Ohio, 43017, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 17, 2020
• Study Start: May 8, 2020
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: January 11, 2022
• Results First Posted: July 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)