N/A
N=110
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.
Non-squamous, Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04750824 ↗Enrolled (actual)
110
Serious AEs
3.6%
Results posted
Sep 2024
Primary outcome: Primary: Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response — 37.5; 76.3; 43.8; 77.8 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Afatinib (Drug); other systemic therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response |
37.5; 76.3; 43.8; 77.8 | — |
| PRIMARY Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria |
34.7; 71.1; 43.8; 72.2 | — |
| PRIMARY Duration of Objective Response (DOR) |
5.851; 13.38; NA; 13.38 | — |
| PRIMARY Duration of Clinical Benefit (DOCB) |
5.85; 13.38; NA; 13.38 | — |
| PRIMARY Progression Free Survival (PFS) |
5.490; 12.886; 6.345; 12.89 | — |
| PRIMARY Time on Treatment (TOT) |
5.42; 5.08; 6.34; 5.08 | — |
| PRIMARY Time to Progression (TTP) |
5.49; 12.89; 6.44; 12.89 | — |
| PRIMARY Overall Survival (OS) |
7.166; 22.551; 9.928; 22.55 | — |
| PRIMARY Number of Patients Who Experienced Any ADRs During Index Treatment Line |
7; 8; 2; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT04750824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.