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

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ClinicalTrials.gov Identifier: NCT02208843
Recruitment Status : Completed
First Posted : August 5, 2014
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Afatinib Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2, 2014
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : June 13, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Afatinib
Afatinib tablet once daily until progression
 Drug: Afatinib
Afatinib tablet once daily until progression


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208843


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

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] April 10, 2014
Statistical Analysis Plan  [PDF] September 22, 2015

More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02208843     History of Changes
Other Study ID Numbers: 1200.217
2014-001077-14 ( EudraCT Number )
First Posted: August 5, 2014    Key Record Dates
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action