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Clinical Trials

Date: 2017-11-15

Type of information: Initiation of the trial

phase:

Announcement: initiation of the trial

Company: Boehringer Ingelheim (Germany)

Product: afatinib in first-line, followed by second-line osimertinib

Action mechanism:

  • tyrosine kinase inhibitor. Afatinib is a tyrosine kinase inhibitor. It inhibits signal transduction of all kinase receptors from the ErbB Family, and is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). Over-expression of the Epidermal Growth Factor Receptor (EGFR, also referred to as ErbB1) is found in at least 90% of head and neck cancers and strongly correlates with poor prognosis and overall survival.
  • AZD9291/Osimertinib is an irreversible inhibitor of epidermal growth factor receptors that harbour sensitising mutations (EGFRm) and TKI-resistance mutation T790M. Nearly two out of three patients with NSCLC whose disease progresses after treatment with an EGFR inhibitor develop the T790M mutation, for which treatment options are limited. A small number of patients (approximately 3-5%) have the T790M mutation at NSCLC diagnosis.

Disease: EGFR mutation-positive (M+) advanced non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country: Austria

Trial details:

  • This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed. (NCT03370770)

Latest news:

  • • On December 12, 2017, Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive (M+) advanced non-small cell lung cancer (NSCLC). Data from approximately 190 patients who received tyrosine kinase inhibitors (TKI) – afatinib* in first-line, followed by second-line osimertinib**as part of standard clinical practice – will be analysed to determine total time on treatment.
  • Dr Maximilian Hochmair, Medical Oncologist, Vienna, Austria and coordinating investigator in this trial commented, “Around 50-60% of patients with NSCLC will develop a T790M resistance mutation following treatment with a first- or second-generation TKI. But with osimertinib, which specifically targets the T790M mutation, a second-line targeted treatment is now a realistic option, helping to delay the use of chemotherapy even further. With more targeted treatments available, it is becoming important for clinicians to understand how to optimally sequence treatments to ensure the best outcomes are achieved. This real-world study will generate important insights on resistance mutations and sequencing to further inform long-term treatment planning.”
  • The study, a retrospective review, will analyse data from 65 study centres in 11 countries, to determine the time on treatment of afatinib as first-line therapy in EGFR M+ lung cancer followed by osimertinib for patients with T790M resistance mutation, in a real-world setting. Available data on mutations after treatment with osimertinib will also be collected. With limited information available on the results of sequential treatment with two targeted therapies, this study will provide insight into the impact of TKIs used in this patient population and subsequent chemotherapy treatment. The sequence of treatment with TKIs may be a key determinant of long-term patient outcomes in EGFR M+ NSCLC.
  • Results from GioTag are expected to be available in 2018.
 

Is general: Yes