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.

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

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

Study Overview

• Status: Completed
• Conditions: Non-squamous, Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Afatinib; Drug: other systemic therapy

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dublin, Ohio, United States, 43017
      • Cardinal Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All afatinib patients	Drug: Afatinib; Afatinib; Other Names: Gilotrif®
All non-afatinib (other systemic therapies)	Drug: other systemic therapy; other systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response	ORR was defined as the percentage 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 (response based on the scan where the patient showed the best response to treatment (not progression)). Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported.	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.
Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria	ORR based on lesion measurements and RECIST v1.1 criteria is reported. ORR was defined as the percentage 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): CR: Disappearance of all target lesions or disappearance of all non-target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	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.
Duration of Objective Response (DOR)	DOR was defined as the time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death. Duration of response is reported for those patients who had a complete or partial response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date.	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.
Duration of Clinical Benefit (DOCB)	DOCB was defined as the 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. DOCB reported for those patients who had a complete, partial or response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date.	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.
Progression Free Survival (PFS)	PFS was defined as time from initiation of a line of therapy until disease progression or death; patients on therapy at the time of data cut-off were censored on the last date of treatment. Patients who discontinued a line of therapy for a reason other than disease progression but who subsequently die prior to the receipt of any other therapy were considered an event on the date of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeter (mm).	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.
Time on Treatment (TOT)	TOT was defined as time from initiation of a line of therapy until discontinuation for any reason. Patients on therapy at the time of data cut-off were censored on the last date of treatment.	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.
Time to Progression (TTP)	TTP was defined as time from initiation of a line of therapy until discontinuation due to disease progression. Patients on therapy or those who discontinued due to a reason other than disease progression were censored on the last date of treatment.	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.
Overall Survival (OS)	OS was defined as time from initiation of any therapy in the metastatic setting until death. Patients alive at the time of data cut-off were censored on the last date the patient was seen by the provider/clinic.	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.
Number of Patients Who Experienced Any ADRs During Index Treatment Line	Number of patients who experienced any averse drug reactions (ADRs) during index treatment line is reported. An ADR was defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility.	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 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Afatinib
• Other Study ID Numbers: 1200-0335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No