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.

NCT04750824 | Completed Results FDA Drug

• 1 other identifier: 1200-0335
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-squamous, Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (2)

All afatinib patients

Drug: Afatinib

All non-afatinib (other systemic therapies)

Drug: other systemic therapy

Interventions

Afatinib DRUG

Afatinib

Also known as: Gilotrif®

All afatinib patients

other systemic therapy DRUG

other systemic therapy

All non-afatinib (other systemic therapies)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• \- Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than afatinib

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: October 15, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)