NCT04533321

A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Clinical objectives: 1. To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism. 2. To determine the tolerability of afatinib in chemo-relapsed patients with germline MET-N375S polymorphism. Research objectives: 1. To determine the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in various cancers, particularly head and neck cancers and lung cancers. 2. To establish tumour cell lines, spheroids of xenografts for drug screening. Endpoints of study: 1. To determine the response rate of SCC HN/lung with Met-N375S to afatinib. 2. The secondary endpoints include progression-free survival and toxicity. 3. Frequency of MET mutations and TP53 mutations in patients with cancer.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Afatinib	Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-08-31
• Last updated: 2020-08-31

Locations

1 site across 1 country: Singapore