#1 Clinical Trials Search in Europe

Afatinib

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.

Table of Contents

Clinical trial overview

These studies are investigating Afatinib in people with specific cancers, mainly lung cancer and one type of head and neck cancer.[1][2][3][4] 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.[1][2][3][4]

Lung cancer studies

Three of the four trials focus on non-small cell lung cancer (NSCLC), which is the main cancer type studied here.[1][2][4] 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.[1]

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.[2] 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.[2]

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.[4] 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.[4]

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.[3] 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.[3]

Trial phases and study designs

The Afatinib studies include Phase 2, Phase 3, and Phase IV research.[2][3] 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.[1][2][4] 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.[2]

All four trials are interventional, which means the researchers assign a treatment and then measure the results.[1][2][3][4] The treatment groups include Afatinib alone in some studies and Afatinib compared with or sequenced after other EGFR inhibitors in others.[1][2][4]

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.[1] 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.[2]

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.[3] In the PACC mutation study, the main outcomes are progression-free survival and confirmed ORR, both checked by blinded independent central review.[4]

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.[1][2][3][4] 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.[1][2][3][4]

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.[3][4] All of the listed studies are currently authorised.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2024-518172-31-01 Phase 3 EGFR-mutated non-small cell lung cancer not amenable for curative treatment Authorised 200
NCT04413201 Phase 3 EGFRmutated/T790M Mutation negative non-squamous NSCLC Authorised 126
2024-511477-29-00 Phase 2 Unresectable and/or metastatic locoregionally advanced squamous cell carcinoma linked to Fanconi anemia Authorised 25
2025-522151-26-00 Phase 3 Locally advanced or metastatic NSCLC with EGFR PACC uncommon mutations Authorised 388

FAQ

  • Who can take part in Afatinib clinical trials? The trials focus on people with specific cancers, especially EGFR-mutated non-small cell lung cancer. One study also includes patients with unresectable or metastatic squamous cell carcinoma linked to Fanconi anemia.
  • What conditions are being studied with Afatinib? Afatinib is being studied in EGFR-mutated non-small cell lung cancer, including uncommon EGFR mutation groups, and in advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. These are cancers that are either advanced, metastatic, or not suitable for curative treatment.
  • What phases are the Afatinib trials in? The trials include Phase 2, Phase 3, and Phase IV studies. This means they are testing Afatinib in later-stage research, often to compare it with other EGFR inhibitors or to measure how well it works in real-world use.
  • What are the main trial goals? The studies aim to measure progression-free survival, time to treatment failure, and objective response rate. In simple terms, they want to know how long the cancer stays under control and how many patients have a clear tumor response.
  • Is Afatinib being studied alone or with other treatments? Both approaches are being studied. Some trials compare Afatinib with other EGFR inhibitors such as osimertinib, while another study looks at Afatinib as part of a treatment sequence.

Ongoing Clinical Trials on Afatinib

  • Study comparing firmonertinib with osimertinib or afatinib for patients with advanced lung cancer with uncommon EGFR mutations

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Italy Spain

  • Study on EGFR-Mutated Lung Cancer: Evaluating Dacomitinib, Afatinib, and Osimertinib for Patients Not Suitable for Curative Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Safety and Effectiveness of Afatinib for Fanconi Anemia Patients with Advanced Squamous Cell Carcinoma in the Oral Cavity, Oropharynx, Hypopharynx, or Larynx

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study on Afatinib and Osimertinib for Patients with EGFR-Mutated, T790M Negative Non-Squamous Non-Small Cell Lung Cancer in First-Line Treatment

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany

Glossary

  • EGFR-mutated: A cancer that has a change in the EGFR gene. This change can affect how the cancer grows and how it may respond to treatment.
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer. The trials focus on people with advanced or metastatic forms of this cancer.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Locally advanced: Cancer that has grown more widely in the area where it started, but may not have spread to distant organs.
  • Unresectable: Cancer that cannot be removed completely with surgery.
  • Progression-free survival (PFS): The length of time during and after treatment when the cancer does not get worse.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • EGFR inhibitor: A treatment that targets the EGFR pathway. In these trials, it is used as a comparison treatment or part of a treatment sequence.
  • Phase IV: A later stage of clinical research done after a treatment is already in use, often to learn more about its benefit and safety in routine care.
  • T790M mutation: A specific EGFR gene change mentioned in one lung cancer study. The trial compares treatment strategies in patients with or without this mutation.

References

  1. https://clinicaltrials.gov/study/2024-518172-31-01
  2. https://clinicaltrials.eu/trial/study-on-afatinib-and-osimertinib-for-patients-with-egfr-mutated-t790m-negative-non-squamous-non-small-cell-lung-cancer-in-first-line-treatment/
  3. https://clinicaltrials.gov/study/2024-511477-29-00
  4. https://clinicaltrials.gov/study/2025-522151-26-00