Carcinoma, Non-Small-Cell LungPhase 4NCT02514174
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
A Phase 4 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung and ErbB Receptors, run by Boehringer Ingelheim at 10 sites in United States.
Trial summary
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, ErbB Receptors
- What is being tested?
- Afatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Aug 2015to 25 Apr 2019
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th edition (R12-4710)
- Evidence of common EGFR mutation (Del 19 and/or L858R)
- Age >= 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
- Further inclusion criteria apply.
Who cannot join
- Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
- Prior systemic therapy for metastatic or recurrent NSCLC.
- Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
- Radiotherapy within 4 weeks prior to start of study treatment, except as follows:
- Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or
- Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Show all 10Show fewer
- Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
- Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
- Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
- Further exclusion criteria apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
City of Hope
Duarte, California, 91010
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017
University of Miami
Miami, Florida, 33136
Mayo Clinic-Arizona
Scottsdale, Arizona, 85250
Baystate Health D'Amour Center for Cancer Care
Springfield, Massachusetts, 01199
Montefiore Medical Center
The Bronx, New York, 10467
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.
- Conditions
- Carcinoma, Non-Small-Cell Lung, ErbB Receptors
- 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
afatinib starting at 30 mg daily dose
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | afatinib starting at 30 mg daily dose Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Measured: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary outcomes (5)
Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher
Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Measured: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Measured: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Measured: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Measured: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events
Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events.
Measured: On-treatment period, up to 1057 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start18 Aug 2015
- Primary completion28 Mar 2019
- Study completion25 Apr 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02514174
- Sponsor's protocol ID
- 1200.209
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2015
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
- ClinicalTrials.gov ID
- NCT02514174
- Acronym / sponsor ID
- 1200.209
- Conditions
- Carcinoma, Non-Small-Cell Lung, ErbB Receptors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.
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: Afatinibafatinib starting at 30 mg daily dose |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th edition (R12-4710)
- Evidence of common EGFR mutation (Del 19 and/or L858R)
- Age >= 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
- Further inclusion criteria apply.
Key exclusion criteria (10 listed)
- Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
- Prior systemic therapy for metastatic or recurrent NSCLC.
- Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
- Radiotherapy within 4 weeks prior to start of study treatment, except as follows:
- Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
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 |
|---|---|---|
| Afatinibafatinib starting at 30 mg daily dose | Drug | Afatinib |
Primary outcome
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
5 secondary outcomes
Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
Time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events
Time frame: On-treatment period, up to 1057 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung and ErbB Receptors, run by Boehringer Ingelheim at 10 sites in United States.
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 10 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Mar 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?
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib (time frame: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2020.