Carcinoma, Non-Small-Cell LungNCT02047903
GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Afatinib
- How many people
- 161 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC-EGFR mutation positive
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
Study Design:
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Afatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
50, 40, 30 or 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Not described Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 12 months
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the initial dose of study drug until end of the treatment period, up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study start5 Mar 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047903
- Sponsor's protocol ID
- 1200.205
- Status last verified
- Dec 2019
- First submitted
- 27 Jan 2014
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Brueckl WM, Reck M, Schafer H, Neben K, Griesinger F, Rawluk J, Kruger S, Kokowski K, Ficker JH, Moller M, Schueler A, Laack E. Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study. J Geriatr Oncol. 2023 Jan;14(1):101394. doi: 10.1016/j.jgo.2022.10.009. Epub 2022 Oct 30.
PubMed 36323612
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02047903
- Acronym / sponsor ID
- 1200.205
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib | – | Drug: Afatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC-EGFR mutation positive
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib50, 40, 30 or 20 mg | Drug | Afatinib |
Primary outcome
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.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.
Disease Control Rate (DCR)
Time frame: From the initial dose of study drug until end of the treatment period, up to 48 months.
Progression Free Survival (PFS)
Time frame: 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)
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
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.
Treatment Duration
Time frame: 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)
Time frame: Up to 48 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36323612Brueckl WM, Reck M, Schafer H, Neben K, Griesinger F, Rawluk J, Kruger S, Kokowski K, Ficker JH, Moller M, Schueler A, Laack E. Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study. J Geriatr Oncol. 2023 Jan;14(1):101394. doi: 10.1016/j.jgo.2022.10.009. Epub 2022 Oct 30.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) Rate After 12 Months (time frame: After 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.