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Completed

NCT Number: 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

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.

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Key information

Conditions

Non-squamous, Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

afatinib

Drug

drug

Other names: Giotrif®

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

    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.

Secondary outcomes

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

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

    Overall survival (OS) is defined as the time from the start of afatinib until death for any reason. Subjects who have not died at the time of the statistical analysis were censored at the time they had the last known afatinib contact.

    The median survival time was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method. The median OS was not estimable due to the limited number of death events.

  2. 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

    Time frame: 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.

    The objective response rate (ORR) is defined as the percentage of subjects treated with first-line afatinib with best overall response of complete response (CR), defined by the disappearance of all target lesions, and partial response (PR), defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The tumor response was evaluated by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

    The Clopper-Pearson method was used to provide an estimation of the ORR with 95% confidence interval.

  3. Number of Patients With Any Adverse Event (AE)

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

    Number of patients treated with first-line afatinib with any adverse event.

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

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

    Number of patients treated with first-line afatinib with treatment emergent serious adverse events (SAEs). SAEs are untoward medical occurrences that result in death, are life threatening, require inpatient hospitalisation, require prolongation of existing hospitalisation, result in persistent or significant disability/incapacity, result in a congenital anomaly/birth defect, or are deemed serious for any other medically important reason.

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

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

    Number of patients treated with first-line afatinib with any adverse event associated with the use of afatinib.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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