In short
Clinical trials investigating Afatinib are studying how well it works and how safe it is in different cancer groups. The main focus is on people with EGFR-mutated lung cancer and some patients with advanced squamous cell carcinoma linked to Fanconi anemia. These studies look at treatment sequences, response rates, and progression-free survival.
Key points
- Clinical trials investigating Afatinib are mostly focused on cancer, especially EGFR-mutated non-small cell lung cancer. One study also looks at advanced squamous cell carcinoma linked to Fanconi anemia. The trials include Phase 2, Phase 3, and Phase IV research. They are testing Afatinib alone, in treatment sequences, or against other EGFR inhibitors such as osimertinib. Main outcomes include progression-free survival, time to treatment failure, and objective response rate. The target groups are patients with advanced, metastatic, or non-curable disease.
Clinical trial overview
These studies are investigating Afatinib in people with specific cancers, mainly lung cancer and one type of head and neck cancer. The trials are designed to learn whether Afatinib can help control disease, how it compares with other EGFR inhibitors, and how effective it is in different patient groups.
Lung cancer studies
Three of the four trials focus on non-small cell lung cancer (NSCLC), which is the main cancer type studied here. One Phase 3 study looks at people with EGFR-mutated NSCLC who are not suitable for curative treatment and are candidates for an EGFR inhibitor as first-line therapy, meaning treatment given first after diagnosis in this setting.
Another Phase 3 study compares a treatment sequence of Afatinib followed by osimertinib with osimertinib alone in people with EGFRmutated/T790M Mutation negative non-squamous NSCLC. The main question is whether the sequence can improve the time to EGFR-TKI failure within 24 months in the T790M positive group, which means how long the treatment strategy keeps working before it stops helping.
A third Phase 3 study is testing firmonertinib against the investigator’s choice of EGFR inhibitor, including Afatinib or osimertinib, in people with locally advanced or metastatic NSCLC with EGFR PACC uncommon mutations. Its main outcomes are progression-free survival and confirmed overall response rate, both measured by blinded independent central review, which means experts who do not know which treatment was given review the results to reduce bias.
Head and neck cancer study
One Phase 2 study is looking at Afatinib in patients with Fanconi anemia who have unresectable and/or metastatic locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. This is a smaller study with 25 participants, and its main goal is to measure antitumor activity using objective response rate according to RECIST v1.1, a standard system for checking whether a tumor has shrunk or grown.
Trial phases and study designs
The Afatinib studies include Phase 2, Phase 3, and Phase IV research. Phase 2 studies usually explore whether a treatment shows enough activity to continue, while Phase 3 studies compare treatments in larger groups and look for stronger evidence of benefit. The Phase IV study in AFAMOSI is a later-stage study that compares Afatinib followed by osimertinib with osimertinib alone in the first-line setting.
All four trials are interventional, which means the researchers assign a treatment and then measure the results. The treatment groups include Afatinib alone in some studies and Afatinib compared with or sequenced after other EGFR inhibitors in others.
Outcomes being measured
The main outcome in the ERIS study is progression-free survival (PFS), which measures how long the cancer does not get worse after treatment starts. In AFAMOSI, the main outcome is time to EGFR-TKI failure within 24 months, which shows how long the treatment strategy works before it is considered to have failed.
In the Fanconi anemia study, the main endpoint is objective response rate (ORR) according to RECIST v1.1, meaning the share of patients whose tumors shrink or disappear on scans. In the PACC mutation study, the main outcomes are progression-free survival and confirmed ORR, both checked by blinded independent central review.
Who the trials are for
These trials are not for general use in all cancer patients; they are aimed at very specific groups defined by cancer type and gene changes. The target populations include people with EGFR-mutated NSCLC, people with EGFRmutated/T790M Mutation negative non-squamous NSCLC, people with NSCLC and EGFR PACC uncommon mutations, and patients with Fanconi anemia-related advanced squamous cell carcinoma of the upper aerodigestive tract.
Enrollment sizes range from 25 patients in the smaller Phase 2 study to 388 patients in the largest Phase 3 study, showing that the trials vary in scale. All of the listed studies are currently authorised.