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.

Non-squamous, Non-Small Cell Lung Cancer Clinical Trial

Official title:

Assessment of Real-World Outcomes Associated With Afatinib (Gilotrif) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750824
• Other study ID #: 1200-0335
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults, 18 years of age or older, at the time of diagnosis with any solid tumor.

• Confirmed NRG1 gene fusion in any solid tumor.

• Initiated afatinib or other systemic therapy (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01/01/2017 through 03/31/2020.

• Followed up for =3 months after initiation of afatinib or other systemic therapy (unless deceased prior to 3 months of follow-up).

Exclusion Criteria:

• Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than afatinib

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-squamous, Non-Small Cell Lung Cancer

Intervention

Drug:
• Afatinib
Afatinib
• other systemic therapy
other systemic therapy

Locations

Country	Name	City	State
United States	Cardinal Health	Dublin	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a complete response (CR) or partial response (PR)	out of all patients (CR+PR/all patients) at initial response assessment and best response	1 day
Secondary	Duration of clinical benefit (DOCB)	time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death	1 day
Secondary	Duration of response	time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death	1 day
Secondary	Time from initiation of a line of therapy until discontinuation for any reason		1 day
Secondary	Time from initiation of a line of therapy until discontinuation due to disease progression		1 day
Secondary	Time from initiation of a line of therapy until disease progression or death		1 day
Secondary	Time from initiation of any therapy in the metastatic setting until death		1 day
Secondary	Number of patients experiencing an adverse event		1 day

External Links

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