Carcinoma, Non-Small-Cell LungNCT02751879

Real World Data on Gi(l)Otrif® Dose Adjustment

An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 29 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
How many people: 228 participants
Where: 29 sitesin 13 countries
Study dates: 24 Nov 2016to 30 Sep 2017
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 patients

Who may be able to join

Age = 18 years
Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)

Who cannot join

Any contraindication to Gi(l)otrif® as specified in label.
Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is > or = 6 months.
Patients treated with Gi(l)otrif® within an interventional trial.

Trial locations and contacts

29 sites in 13 countries.

Country

City, postcode or hospital

29 sites in 13 countries

France4 sites

HOP Jean Minjoz
Besançon, 25030
HOP Dijon, Cardio-Pneumo, Dijon
Dijon, 21079
HOP Européen G. Pompidou
Paris, 75908
HOP Tenon
Paris, 75970

Other trials in France

Germany3 sites

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45147
Klinikum Nürnberg
Nuremberg, 90419
Pius-Hospital, Oldenburg
Oldenburg, 26121

Other trials in Germany

Mexico3 sites

Centro Medico ABC
Mexico City, 01120
Organización para Cuidado Integral en Oncología S.A de C.V
Monterrey, 64060
Unidad de Cancerologia
Zapopan, 45050

Other trials in Mexico

Poland3 sites

Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz
Bydgoszcz, 85796
Grzegorz Czyzewicz Specialised Medical Practice, Cracow
Cracow, 31331
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
Poznan, 60-569

Other trials in Poland

South Korea3 sites

Yeungnam University Medical Center
Daegu, 705-703
Chonbuk National University Hospital
Jeonju, 54907
Pusan National Univ. Hosp
Pusan, 49241

Other trials in South Korea

United States2 sites

Levine Cancer Institute
Charlotte, North Carolina, 28201
Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

Italy2 sites

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Azienda Ospedaliera Vito Fazzi
Lecce, 73100

Other trials in Italy

Japan2 sites

Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Kurashiki Central Hospital
Okayama, Kurashiki, 710-8602

Other trials in Japan

Singapore2 sites

National University Hospital
Singapore, 119228
National Cancer Centre
Singapore, 169610

Other trials in Singapore

Spain2 sites

Hospital Germans Trias i Pujol
Badalona (Barcelona), 08916
Hospital La Princesa
Madrid, 28006

Other trials in Spain

Austria1 site

SMZ Baumgartner Hoehe Otto Wagner Spital
Vienna, 1140

Other trials in Austria

Canada1 site

BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Taiwan1 site

China Medical University Hospital
Taichung, 40447

Other trials in Taiwan

About this study

Official title: Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

Conditions: Carcinoma, Non-Small-Cell Lung
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.

Study groups in NCT02751879
Study group	Role	What they receive
Non small cell lung cancer (NSCLC)		patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), TKI-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
Measured: From signing the informed consent onwards until the end of the study, up to 104 weeks.
Time on Treatment With Gi(l)Otrif®
Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
Measured: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time to Progression With Gi(l)Otrif®
Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.
Measured: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

Secondary outcomes (2)

Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.
Measured: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.
Measured: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 201630 Sep 2017

First posted26 Apr 2016 (estimated)
Study start24 Nov 2016
Primary completion30 Sep 2017
Study completion30 Sep 2017

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: Cohort
Time perspective: Retrospective
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02751879
Sponsor's protocol ID: 1200.270
Status last verified: Jun 2019
First submitted: 22 Apr 2016
Last updated: 8 Aug 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.
PubMed 30642537

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I

All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
ClinicalTrials.gov ID: NCT02751879
Acronym / sponsor ID: 1200.270
Conditions: Carcinoma, Non-Small-Cell Lung
Study type: Observational
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 24 Nov 2016 (actual)
Primary completion: 30 Sep 2017 (actual)
Study completion: 30 Sep 2017 (actual)
First posted: 26 Apr 2016 (estimated)
Results: Posted 8 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Non small cell lung cancer (NSCLC)	–	–patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), TKI-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: NSCLC patients

Key inclusion criteria (3 listed)

Age = 18 years
Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)

Key exclusion criteria (4 listed)

Any contraindication to Gi(l)otrif® as specified in label.
Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is > or = 6 months.
Patients treated with Gi(l)otrif® within an interventional trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
Time frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.
An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
Time on Treatment With Gi(l)Otrif®
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
Time to Progression With Gi(l)Otrif®
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.

2 secondary outcomes

Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

Results and safety

Results posted to the registry on 8 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gi(l)Otrif ≥ 40 mg	157	157
Gi(l)Otrif ≤ 30 mg	71	71

Primary outcome: Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.

Time frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.. Number. Unit: Percentage of patients (%)

Measure	Gi(l)Otrif ≥ 40 mg n = 157	Gi(l)Otrif ≤ 30 mg n = 71
Grade 1	21.02	21.13
Grade 2	44.59	57.75
Grade 3	24.84	16.90
Grade 4	3.18	0.00

Population analysed: Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.

Primary outcome: Time on Treatment With Gi(l)Otrif®

Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.. Median (95% Confidence Interval). Unit: Months

Measure	Gi(l)Otrif ≥ 40 mg n = 157	Gi(l)Otrif ≤ 30 mg n = 71
Value	18.22 (14.61 to 21.51)	19.41 (12.93 to NA)

Population analysed: FAS

Primary outcome: Time to Progression With Gi(l)Otrif®

Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.. Median (95% Confidence Interval). Unit: Months

Measure	Gi(l)Otrif ≥ 40 mg n = 157	Gi(l)Otrif ≤ 30 mg n = 71
Value	20.03 (18.22 to 23.98)	25.92 (17.3 to NA)

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gi(l)Otrif ≥ 40 mg	11 of 157 (7%)	147 of 157 (93.6%)	8 of 157
Gi(l)Otrif ≤ 30 mg	7 of 71 (9.9%)	68 of 71 (95.8%)	0 of 71

Limitations and caveats (from the sponsor): Due to non-interventional character there were no predefined examinations, retro- and prospective data could be collected, bias regarding AE documentation, participation of patients on treatment was limited due to one exclusion criterion

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30642537Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.
Related InfoLink provided by the sponsor.

Related trials for Carcinoma, Non-Small-Cell Lung

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study
Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I

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

29 sites in 13 countries: 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 29 sites in 13 countries.

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 3 inclusion and 4 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France, Germany, Mexico, Poland, South Korea and 8 more countries. 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 8 Aug 2019). 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?

Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. (time frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.). The study lists 3 primary outcomes in all. 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 NCT02751879, 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 8 Aug 2019.