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

NCT04206787 | Completed Results

• 1 other identifier: 1200-0318
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 10

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.

Conditions

Non-squamous, Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

  Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib. The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.

  From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.

Secondary Outcomes (5)

• Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up

  From first afatinib administration until death, or censoring date. Up to approximately 41 months.

• 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

  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.

• Number of Patients With Any Adverse Event (AE)

  From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months.

• Number of Patients With Treatment-emergent Serious Adverse Events (SAE)

  From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.

• Number of Patients With Any Afatinib-related Adverse Events (AE)

  From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.

Study Arms (1)

Afatinib-treated patients

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.

Drug: Afatinib

Interventions

Afatinib DRUG

drug

Also known as: Giotrif®

Afatinib-treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

West China Hospital

Chengdu, 610041, China

Location

The First Afiliated Hospital, Sun Yet-sen University

Guangzhou, 510080, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Hainan Cancer Hospital

Haikou, 570312, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, 310003, China

Location

China Shenyang Chest Hospital

Shenyang, 110000, China

Location

Shenzhen People's Hospital

Shenzhen, 518020, China

Location

The First Affiliated Hospital of Zhengzhou Unviersity

Zhengzhou, 450052, China

Location

Zhongshan People's Hospital

Zhongshan, 528403, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 20, 2019
• Study Start: May 20, 2020
• Primary Completion: December 18, 2023
• Study Completion: December 22, 2023
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

CN (10)