Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

June 27, 2019 updated by: Boehringer Ingelheim

An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

542

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100071
        • 307 Hospital of PLA
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Changchun, China
        • Jilin Province Cancer Hospital
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Linyi, China, 276002
        • Lin Yi Tumor Hospital
      • Nanjing, China, 210000
        • Jiangsu Cancer Hospital
      • Shanghai, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • India
      • Bangalore, India, 560052
        • Vikram Hospital
      • Bengaluru, India, 560027
        • HCG Hospital
      • Calicut, India, 673002
        • P VS Hospital Pvt Ltd
      • Chennai, India, 600031
        • V S Hospital
      • Delhi, India, 110092
        • Max Super Speciality Hospital, Delhi
      • Hyderabad, India, 500004
        • Global Hospitals
      • Hyderabad, India, 500034
        • Basavatarakam Indo - American Cancer Hospital & Research Ins
      • Jaipur, India, 302004
        • SEAROC Cancer Centre
      • Kolkata,West Bengal, India, 700053
        • B. P. Poddar Hospital & Medial Research Ltd
      • Madurai, India, 625 020
        • Asirvatham Multispeciality Hospital
      • Maharashtra, India, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, India, 422005
        • Shatabdi Superspeciality Hospital
      • Mumbai, India, 400010
        • Prince Aly Khan Hospital
      • Pune, India, 411001
        • Ruby Hall Clinic
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Taiwan
      • Kaohsiung, Taiwan, 824
        • E-Da Hospital
      • Tainan, Taiwan, 704
        • NCKUH
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taoyuan County, Taiwan, 333
        • Chang-Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
  • presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
  • male or female patients age 18 years or older (For India only, male or female patients age >=18 years and <=75 years)

  • adequate organ function, defined as all of the following:

    1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
    2. Platelet count >75,000/mm3
    3. Serum creatinine < 1.5 times of the upper limit of normal
    4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
    5. Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria:

  • prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)

  • radiotherapy within 4 weeks prior to drug administration except as follows:

    1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
    2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
  • known hypersensitivity to afatinib or any of its excipients
  • history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
  • Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.

  • childbearing potential (see Section 4.2.3) who:

    1. are nursing or
    2. are pregnant or
    3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
  • history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
  • previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
  • requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
  • known pre-existing interstitial lung disease
  • presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
  • Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
  • meningeal carcinomatosis
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afatinib
Patient will receive afatinib once daily
Drug: Afatinib
Patient will receive afatinib once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with serious adverse events (SAEs).
From first drug administration up to 28 days after last drug administration, up to 1624 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Symptomatic Progression (TTSP)
Time Frame: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
Time Frame: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with drug-related (afatinib-related) adverse events.
From first drug administration up to 28 days after last drug administration, up to 1624 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2013

Primary Completion (Actual)

July 6, 2018

Study Completion (Actual)

July 6, 2018

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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