Afatinib Osimertinib Sequencing NIS

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Boehringer Ingelheim

Status

Completed

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Afatinib
Drug: Osimertinib

Study type

Observational

Funder types

Industry

Identifiers

NCT03370770
1200-0286

Details and patient eligibility

About

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.

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
  • The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
  • Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
  • Patients treated with osimertinib within an EAP/CUP or regular clinical practice
  • Age ≥ 18 years
  • Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)

Exclusion criteria

  • Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
  • Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)

Trial design

204 participants in 1 patient group

patients with EGFR mutation-positive NSCLC
Description:
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
Treatment:
Drug: Osimertinib
Drug: Afatinib

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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