Clinical trial NCT04750824: 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.
Official title: Assessment of Real-World Outcomes Associated With Afatinib (Gilotrif) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-squamous, Non-Small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers will select patients meeting the study eligibility criteria as described below. Providers will be asked to select eligible patients chronologically, starting with the first patient who first initiated any line of afatinib or chemotherapy, on or after 01/01/2017 through 03/31/2020.

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.


Eligibility 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

Primary outcomes:
measure: Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Duration of Objective Response (DOR)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Duration of Clinical Benefit (DOCB)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Progression Free Survival (PFS)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Time on Treatment (TOT)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Time to Progression (TTP)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Overall Survival (OS)
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
measure: Number of Patients Who Experienced Any ADRs During Index Treatment Line
timeFrame: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health
state: Ohio
Study officials:
References: