Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

June 1, 2018 updated by: Boehringer Ingelheim

An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy

The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Egypt
      • Alexandria, Egypt, 21131
        • Clinical Research Center, Alexandria University Hospital
      • Cairo, Egypt, 11796
        • National Cancer Institute, Cairo University
      • Cairo, Egypt, 12311
        • kasr Al Ainy Hospital
  • Malaysia
      • Nilai, Malaysia, 71800
        • Nilai Medical Centre
  • Philippines
      • Baguio City, Philippines, 2600
        • Baguio General Hospital and Medical Center
      • Taguig, Philippines, 1634
        • St. Luke's Medical Center
  • Poland
      • Gdansk, Poland, 80-952
        • University Clinical Center, Gdansk
      • Szczecin-Zdunowo, Poland, 70-891
        • Specialist Hospital, Szczecin-Zdunowo
      • Warsaw, Poland, 02-781
        • Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
  • Romania
      • Braila, Romania, 810303
        • Braila County Emergency Hospital, Medical Oncology
      • Bucharest, Romania, 022328
        • Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
      • Craiova, Romania, 200347
        • Sf. Nectarie Oncology Center, Craiova
      • Iasi, Romania, 700483
        • Regional Oncology Institute of Iasi, Medical Oncology
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
      • Belgrade, Serbia, 11129
        • Clinical Center of Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Sremska Kamenica, Serbia, 21204
        • Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10310
        • Wattanosoth Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital

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:

  1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
  2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
  3. Measureable disease according to RECIST 1.1.
  4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
  5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  6. Adequate organ function.

Exclusion criteria:

  1. More than one line of prior therapy for disease.
  2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
  3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
  4. Known pre-existing interstitial lung disease.

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
Afatinib tablet once daily until progression
Drug: Afatinib
Afatinib tablet once daily until progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 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.

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)

October 2, 2014

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

June 13, 2017

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.217
  • 2014-001077-14 (EudraCT Number)

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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