Clinical trial · Expanded Access
Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)
Assessment of Prospective Real-world Outcomes Based on Single-patient Protocol Data Collection of Afatinib (GILOTRIF®) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions
NCT05107193CI-TRIAL-00062042no longer availableClinicalTrials.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)
Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner. The specific NRG1 gene fusion will be identified by a specialized molecular testing lab.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| afatinib | Drug | Afatinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria to participate in this program: * Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring NRG1 gene fusions characterized as follows: * Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing) * Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing) * Patient must have measurable or evaluable lesions (according to RECIST 1.1). * At least 18 years of age at the time of consent. Exclusion Criteria: * Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication. * Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available * Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB) * Any patient considered ineligible by the treating physician.
References
Publications (0)
Data not yet available
No reference posted for this study.