Clinical trial · Interventional
Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma
Phase II Study of Afatinib Plus Chemotherapy in Patients With Esophageal and Lung Squamous Cell Carcinoma
- 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)
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- afatinib 40mg bid plus chemotherapy
- description
- afatinib 40mg bid po plus chemotherapy
- interventionNames
- Drug: Afatinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
- through study completion, an average of 2 year
- description
- Progression-Free-Survival
Secondary outcomes (1)
- measure
- ORR
- timeFrame
- through study completion, an average of 2 year
- description
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures * Life expectancy \> 10 months * Karnofsky Performance Status ≥ 70 * Diagnosis of histological or cytologically confirmed squamous lung cancer or esophageal squamous cancer, * Age ≥ 18 years * Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin \> 9 g/dL; platelets \> 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0 * Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. Exclusion Criteria: * Poor compliance, reluctant to undergo research medication, or follow-up. * Tumor inaccessible for biopsy * It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study. * It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
References
Publications (0)
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