Carcinoma, Non-Small-Cell LungNCT02285361

GIOTRIF rPMS in Korean Patients With NSCLC

An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

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

Trial summary

To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) Read more about this study

Who is it for?: Ages 19 to 110 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: GIOTRIF 20mg, GIOTRIF 40mg and GIOTRIF 30mg
How many people: 1,272 participants
Where: 1 siteSouth Korea
Study dates: 31 Oct 2014to 31 Dec 2019
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 19 to 110 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: NSCLC in Korea

Who may be able to join

Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
Age = 19 years at enrolment
Patients who have signed on the data release consent form

Who cannot join

Known hypersensitivity to afatinib or any of its excipients
Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Patients for whom GIOTRIF® is contraindicated according to the local label

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Multiple Locations

Other trials in South Korea

About this study

Official title: A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy

To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: GIOTRIF 20mg, GIOTRIF 40mg, GIOTRIF 30mg
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.

GIOTRIF 20mgDrug
NSCLC with GIOTRIF 20mg
GIOTRIF 40mgDrug
NSCLC with GIOTRIF 40mg
GIOTRIF 30mgDrug
NSCLC with GIOTRIF 30mg

Study groups in NCT02285361
Study group	Role	What they receive
GIOTRIF		Not described Receives: Drug: GIOTRIF 20mg; Drug: GIOTRIF 40mg; Drug: GIOTRIF 30mg

What is being measured

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

Percentage of Participants With Adverse Drug Reactions (ADRs)
Percentage of participants with Adverse Drug Reactions (ADRs).
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

Secondary outcomes (3)

Progression-Free Survival (PFS) Rate at 48 Weeks
Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC).
If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression.
PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve.
Measured: From week 0 until week 48. Up to 48 weeks.
Percentage of Participants With Best Response
Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site.
Tumour response according to investigator's assessment
Each patient will be assigned to one of the following categories:
1. Complete response (CR)
2. Partial response (PR)
3. Stable disease (SD)
4. Progressive disease (PD)
5. Not evaluable for response, reasons to be specified (e.g. early death, tumour assessments incomplete, etc.)
Measured: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
Overall Survival (OS)
Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS.
For patients with known date of death:
OS [days] = date of death - (date of start of treatment) + 1
For patients known not death case:
OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1.
Measured: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

Timeline

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

31 Oct 201431 Dec 2019

First posted7 Nov 2014 (estimated)
Study start31 Oct 2014
Primary completion31 Dec 2019
Study completion31 Dec 2019

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.
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: Prospective
Enrolment: 1,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02285361
Sponsor's protocol ID: 1200.235
Status last verified: Feb 2021
First submitted: 20 Oct 2014
Last updated: 24 Feb 2021
Results posted: Yes, on ClinicalTrials.gov

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

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All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
ClinicalTrials.gov ID: NCT02285361
Acronym / sponsor ID: 1200.235
Conditions: Carcinoma, Non-Small-Cell Lung
Study type: Observational
Recruitment status: Completed
Enrolment: 1,272 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 Oct 2014 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 7 Nov 2014 (estimated)
Results: Posted 24 Feb 2021

Clinical summary

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

To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Study design

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

Arm	Type	Receives
GIOTRIF	–	Drug: GIOTRIF 20mg, Drug: GIOTRIF 40mg, Drug: GIOTRIF 30mg

Who may qualify

Ages: 19 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: NSCLC in Korea

Key inclusion criteria (3 listed)

Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
Age = 19 years at enrolment
Patients who have signed on the data release consent form

Key exclusion criteria (3 listed)

Known hypersensitivity to afatinib or any of its excipients
Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Patients for whom GIOTRIF® is contraindicated according to the local label

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
GIOTRIF 20mgNSCLC with GIOTRIF 20mg	Drug	GIOTRIF
GIOTRIF 40mgNSCLC with GIOTRIF 40mg	Drug	GIOTRIF
GIOTRIF 30mgNSCLC with GIOTRIF 30mg	Drug	GIOTRIF

Primary outcome

Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Percentage of participants with Adverse Drug Reactions (ADRs).

3 secondary outcomes

Progression-Free Survival (PFS) Rate at 48 Weeks
Time frame: From week 0 until week 48. Up to 48 weeks.
Percentage of Participants With Best Response
Time frame: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
Overall Survival (OS)
Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

Results and safety

Results posted to the registry on 24 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GIOTRIF®	1,272	1,221

Primary outcome: Percentage of Participants With Adverse Drug Reactions (ADRs)

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.. Number. Unit: Percentage of participants

Measure	GIOTRIF® n = 1220
Value	89.92

Population analysed: All Participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 1 subject was excluded from the set based on disease indication.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GIOTRIF®	442 of 1,266 (34.9%)	1,076 of 1,266 (85%)	52 of 1,266

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Carcinoma, Non-Small-Cell Lung

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Not yet recruitingPhase 1/2
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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 South Korea.

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 3 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 24 Feb 2021. 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 South Korea. 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 24 Feb 2021). 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 Participants With Adverse Drug Reactions (ADRs) (time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.). 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 NCT02285361.

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 24 Feb 2021.