Clinical trial · Observational
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
NCT04750824CI-TRIAL-00080535completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-squamous, Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
| other systemic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- All afatinib patients
- interventionNames
- Drug: Afatinib
- label
- All non-afatinib (other systemic therapies)
- interventionNames
- Drug: other systemic therapy
Primary outcomes (9)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.