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.

NCT ID: NCT04750824

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-12-20

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.

Detailed Description

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Conditions

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Non-squamous, Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All afatinib patients

Afatinib

Intervention Type DRUG

Afatinib

All non-afatinib (other systemic therapies)

other systemic therapy

Intervention Type DRUG

other systemic therapy

Interventions

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Afatinib

Afatinib

Intervention Type DRUG

other systemic therapy

other systemic therapy

Intervention Type DRUG

Other Intervention Names

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Gilotrif®

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardinal Health

Dublin, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1200-0335

Identifier Type: -

Identifier Source: org_study_id

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