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 Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Afatinib cohort Afatinib cohort |
Drug: Afatinib
Afatinib
|
| other systemic therapy cohort other systemic therapy cohort |
Drug: other systemic therapy
other systemic therapy
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with a complete response (CR) or partial response (PR) [1 day]
out of all patients (CR+PR/all patients) at initial response assessment and best response
Secondary Outcome Measures
- Duration of clinical benefit (DOCB) [1 day]
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
- Duration of response [1 day]
time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardinal Health | Dublin | Ohio | United States | 43017 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1200-0335