Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy. There is also evidence of improvement of progression free survival of patients with metastatic/recurrent SCC of the head and neck after failure of chemotherapy in patients treated with afatinib. Therefore, treatment of patients with these 2 conditions with afatinib is not experimental, and will follow conventional clinical management.

NCT04533321

Conditions

1. Squamous Cell Carcinoma

Interventions

1. Drug: Afatinib

MeSH:Carcinoma Carcinoma, Squamous Cell

HPO:Carcinoma Squamous cell carcinoma

using immunohistochemistry.. MET-N375S mRNA copy number. --- N375S ---

Customised probes detecting wildtype MET allele or MET-N375S allele are designed to for genotyping (homozygous/heterozygous).. Presence of MET and HER2 amplification using fluorescence in situ hybridization (FISH). --- N375S ---

FFPE samples retrieved from patients genotyped with MET-N375S polymorphism will be subjected to MET and HER2 testing Abbott PathVysion DNA test kits. --- N375S ---

5. Clinical study will enroll patients genotyped positive for MET-N375S polymorphism. --- N375S ---

To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism. --- N375S ---

2. To determine the tolerability of afatinib in chemo-relapsed patients with germline MET-N375S polymorphism. --- N375S ---

To determine the response rate of SCC HN/lung with Met-N375S to afatinib. --- N375S ---

This study focuses on advanced lung and head and neck SCC tumours, with adjacent normal lung tissues. Biopsies will be performed in National University Health System, Singapore (NUHS) as part of participants' standard care. Patient blood was also required for extraction of cell free DNA (cfDNA) and genomic DNA (gDNA). Patients' medical records will also be reviewed for the purpose of this study.

NCT03938012

Conditions

1. Squamous Cell Carcinoma of the Lung
2. Squamous Cell Carcinoma of the Head and Neck

MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Lung Neoplasms

HPO:Carcinoma Neoplasm of the lung Squamous cell carcinoma

Customised probes detecting wildtype MET allele or MET-N375S allele are designed to for genotyping (homozygous/heterozygous).. Identification of TP53 mutation using Sanger sequencing. --- N375S ---

FFPE samples retrieved from patients genotyped with MET-N375S polymorphism will be subjected to MET and HER2 testing Abbott PathVysion DNA test kits. --- N375S ---