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

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.

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Afatinib

Detailed Description

Study Design:

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

NSCLC-EGFR mutation positive

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Afatinib	Drug: Afatinib; 50, 40, 30 or 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Rate 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.	After 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	From the initial dose of study drug until end of the treatment period, up to 48 months.
Disease Control Rate (DCR)	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	From the initial dose of study drug until end of the treatment period, up to 48 months.
Progression Free Survival (PFS)	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.	From first administration of the trial drug until objective tumour progression or death, up to 48 months.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).	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	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.	From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Treatment Duration	Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.	From the initial dose of study drug until end of the treatment period, up to 48 months.
Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)	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.	Up to 48 months
Percentage of Participants With Treatment Modification	Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.	From the initial dose of study drug until end of the treatment period, up to 48 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: 1200.205