The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer

Boehringer Ingelheim

Status: Completed

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Treatments: Drug: Afatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04206787

1200-0318

Details and patient eligibility

About

This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive
• Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC
• Male and female patients with age ≥18 years
• Written informed consent per local regulatory requirement

Exclusion criteria

• Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted)
• Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment
• Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study

Trial design

72 participants in 1 patient group

Afatinib-treated patients

Description:

Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.

Treatment:

Drug: Afatinib