Carcinoma, Non-Small-Cell LungPhase 3NCT02044380

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 5 sites in Canada.

Completed

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

Official record

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Trial summary

The main aim of this study is to evaluate the safety and tolerability of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine Kinase Inhibitor (TKI) 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 5 sitesCanada
Study dates: Mar 2014to Feb 2016
Phase: Phase 3
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

Who may be able to join

Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology
Male or female patients age >=18 years
Adequate organ function, defined as all of the following:
Absolute neutrophil count (ANC) >1500/mm3
Platelet count>75,000/mm3

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Serum creatinine<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)>45ml/min
Total bilirubin <1.5 times upper limit of (institutional) normal
Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (if related to liver metastases < five times ULN)
Eastern Cooperative Oncology Group (ECOG) score between 0-2
Written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) guidelines and local law
Recovery from any previous therapy related toxicity to <=CTCAE Grade 1 at study entry (except for stable sensory neuropathy <=CTCAE Grade 2 and alopecia)

Who cannot join

Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
Radiotherapy within 28 days prior to drug administration, except as follows:
Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
Single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling
Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial

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Known hypersensitivity to afatinib or any of its excipients
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment
Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended
Childbearing potential who:
are nursing or
are pregnant or
are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug
Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Known pre-existing interstitial lung disease
Presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or Common Terminology Criteria grade =2 diarrhea of any aetiology) based on investigator assessment
Active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier
Meningeal carcinomatosis
Symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of corticosteroid)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Boehringer Ingelheim Investigational Site
Barrie, Ontario
Boehringer Ingelheim Investigational Site
London, Ontario
Boehringer Ingelheim Investigational Site
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Newmarket, Ontario
Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

About this study

Official title: An Open Label Trial of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

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
40, 30, or 20mg tablets taken once daily, dosage depending on tolerability

Study groups in NCT02044380
Study group	Role	What they receive
Afatinib	Experimental	patient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability Receives: Drug: Afatinib

What is being measured

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

Safety Assesment
Safety was assessed by:
1. All serious adverse events (SAEs)
2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib
3. Non-serious AEs assessed by the treating physician as related to afatinib.
Measured: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.

Timeline

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

Mar 2014Feb 2016

First posted24 Jan 2014 (estimated)
Study startMar 2014
Primary completionFeb 2016
Study completionFeb 2016

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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02044380
Sponsor's protocol ID: 1200.48
Status last verified: Feb 2017
First submitted: 22 Jan 2014
Last updated: 31 Mar 2017
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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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Carcinoma, Non-Small-Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Trial of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
ClinicalTrials.gov ID: NCT02044380
Acronym / sponsor ID: 1200.48
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 24 Jan 2014 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Afatinib	Experimental	Drug: Afatinibpatient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability

Who may qualify

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

Key inclusion criteria (12 listed)

Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology
Male or female patients age >=18 years
Adequate organ function, defined as all of the following:
Eastern Cooperative Oncology Group (ECOG) score between 0-2

Key exclusion criteria (21 listed)

Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
Radiotherapy within 28 days prior to drug administration, except as follows:
Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
Known hypersensitivity to afatinib or any of its excipients

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
Afatinib40, 30, or 20mg tablets taken once daily, dosage depending on tolerability	Drug	Afatinib

Primary outcome

Safety Assesment
Time frame: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
Safety was assessed by: 1. All serious adverse events (SAEs) 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib 3. Non-serious AEs assessed by the treating physician as related to afatinib.

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib 40 mg	14	14

Primary outcome: Safety Assesment

Time frame: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.. Number. Unit: Percentage of participants

Measure	Afatinib 40 mg n = 14
Investigator defined drug-related AEs	92.9
AEs leading to dose reduction	35.7
AEs leading to discont. of trial drug	35.7
Serious AEs	21.4

Population analysed: Treated set

Adverse events

Time frame: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib 40 mg	3 of 14 (21.4%)	14 of 14 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to the small number of patients entered and treated in this trial (14 patients) relative to the planned enrollment goal (40 entered patients had been planned), no formal statistical analyses of efficacy data were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Carcinoma, Non-Small-Cell Lung

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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
Non Small Cell Lung Cancer
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)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 5 sites in Canada.

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 12 inclusion and 21 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). 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?

Safety Assesment (time frame: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.). 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 NCT02044380.

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 31 Mar 2017.