Clinical trial NCT04206787: The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer
Official title: Real-world Study on Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-squamous, Non-Small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-12-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be enrolled in this study and will receive afatinib (first-line) and subsequent treatment (second-line) of either 3rd generation EGFR TKI or other treatments

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
timeFrame: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.
Secondary outcomes:
measure: Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up
timeFrame: From first afatinib administration until death, or censoring date. Up to approximately 41 months.
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 by Investigator Review With Afatinib in First-line Treatment
timeFrame: From first afatinib administration until earliest RECIST progression (progressive disease (PD) or death) or the last evaluable assessment in the absence of RECIST progression (PD or death). Up to approximately 40 months.
measure: Number of Patients With Any Adverse Event (AE)
timeFrame: From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months.
measure: Number of Patients With Treatment-emergent Serious Adverse Events (SAE)
timeFrame: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.
measure: Number of Patients With Any Afatinib-related Adverse Events (AE)
timeFrame: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: The First Afiliated Hospital, Sun Yet-sen University
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Haikou
country: China
facility: Hainan Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Shenyang
country: China
facility: China Shenyang Chest Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Unviersity
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
Study officials:
References: