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GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047903
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

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

Detailed Description:
Study Design:
Study Design
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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.
Actual Study Start Date : March 5, 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Afatinib Drug: Afatinib
50, 40, 30 or 20 mg


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) Rate After 12 Months [ Time Frame: After 12 months ]
    The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]
    Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.

  2. Disease Control Rate (DCR) [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]
    Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate

  3. Progression Free Survival (PFS) [ Time Frame: From first administration of the trial drug until objective tumour progression or death, up to 48 months. ]
    PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.

  4. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. ]
    Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).

  5. Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia [ Time Frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. ]
    Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.

  6. Treatment Duration [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]
    Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.

  7. Symptom Control - Time to Worsening (Cough, Dyspnea and Pain) [ Time Frame: Up to 48 months ]
    Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.

  8. Percentage of Participants With Treatment Modification [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]
    Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.


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
Sampling Method:   Probability Sample
Study Population
NSCLC-EGFR mutation positive
Criteria

Inclusion criteria:

  • EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
  • Age >= 18 years
  • No diagnostic or therapeutic measures beyond routine clinical practice are required
  • Patients for whom the treating physician has decided to initiate treatment with GIOTRIF
  • Written informed consent prior inclusion

Exclusion criteria:

  • Contraindication for Afatinib according to the Summary of Product characteristics
  • Participation in another clinical study until 30 days after end of treatment
  • Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
  • Previous treatment with an EGFR-tyrosine kinase inhibitor
  • Patients not willing or not able to fill in quality of life questionnaires
  • Patients with missing or impaired legal capacity
  • Pregnancy
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): NCT02047903


Locations
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Germany
Multiple Locations, Germany
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:
Statistical Analysis Plan  [PDF] December 5, 2017
Study Protocol  [PDF] July 1, 2014

More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02047903    
Other Study ID Numbers: 1200.205
First Posted: January 28, 2014    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020
Last Verified: December 2019
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