18 and older, any sex, with Distal Urethral Cancer or Proximal Urethral Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· 3 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated at 3 months using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Afatinib)
5
Overall Response RateSecondary· Up to 3 years
Includes both complete responses (CR) and partial responses (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to \<10 mm); Partial Response (PR) is defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Group
Value
95% CI
Treatment (Afatinib)
2
Median Progression-free Survival (PFS ) TimeSecondary· Up to 3 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Afatinib)
1.4
1.3 – 2.7
Median Overall Survival (OS) TimeSecondary· Up to 3 years
Estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Afatinib)
5.3
3.7 – 7.4
EGFR Expression StatusSecondary· Baseline
These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was EGFR amplification.
Group
Value
95% CI
Treatment (Afatinib)
5
HER2 Expression StatusSecondary· Baseline
These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was HER2 amplification.
Group
Value
95% CI
Treatment (Afatinib)
4
Adverse events — posted to ClinicalTrials.gov
Time frame: From the initiation of treatment to 28 days after the last administration of trial drugs, up to 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07354100 — Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
· Phase 1, PHASE2
· not yet recruiting
NCT06446661 — Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
· NA
· not yet recruiting
NCT07179315 — A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Tr
· Phase 2
· not yet recruiting
NCT07126561 — Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 25 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02122172.