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

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

Conditions
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Non-squamous, Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Afatinib
* Drug: other systemic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Afatinib cohort<br>Afatinib cohort | Drug: Afatinib<br>* Afatinib<br>|
| other systemic therapy cohort<br>other systemic therapy cohort | Drug: other systemic therapy<br>* other systemic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Time from initiation of a line of therapy until discontinuation for any reason |  | 1 day | 
| Time from initiation of a line of therapy until discontinuation due to disease progression |  | 1 day | 
| Time from initiation of a line of therapy until disease progression or death |  | 1 day | 
| Time from initiation of any therapy in the metastatic setting until death |  | 1 day | 
| Number of patients experiencing an adverse event |  | 1 day |