Carcinoma, Non-Small-Cell LungPhase 4NCT02695290
Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)
A Phase 4 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung and ErbB Receptors, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents. Read more about this study
- Who is it for?
- Ages 18 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to 26 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, 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. The staging is based on American Joint Committee on Cancer (AJCC) Tumor Node Metastatic (TNM) classification of malignant tumors, 7th edition
- Evidence of common EGFR activating mutations (Del 19 and/or L858R)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3
- Adequate organ function, defined as all of the following:
- Absolute neutrophil count (ANC) > 1500 / mm3
Show all 14Show fewer
- Platelet count >75,000 / mm3.
- Baseline creatinine of < or = 1.5 g/dl or, if > 1.5, an estimated creatinine clearance of > 45 ml/min
- Total Bilirubin < 1.5 times upper limit of institutional normal (ULN)
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) < three times ULN (if related to liver metastases < five times ULN)
- Recovery from any previous therapy related toxicity to< or = Grade 1 at study entry (except for stable sensory neuropathy < or =Grade 2 and alopecia)
- Life expectancy of at least three months
- Written informed consent that is consistent with International Council on Harmonization- Good Clinical Practice (ICH-GCP) guidelines
- Age 18 or older
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 including prior treatment with EGFR targeting small molecules or antibodies. Note: radiotherapy alone and adjuvant/neoadjuvant treatment is not counted as a line of therapy.
- 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:
- i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) Single dose palliative treatment (e.g Stereotactic Radio Surgery(SRS) or Stereotactic Body Radiation Therapy) (SBRT) for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
- Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
Show all 18Show fewer
- Women of child-bearing potential (WOCBP) and men who are able to father a child, or use adequate contraception prior to study entry, for the duration of study participation and for at least 28 days after treatment has ended.
- Presence of an active infection or with a fever > 38.5 C within 3 days of the first scheduled day of dosing
- Known hypersensitivity to afatinib or the excipients of afatinib
- Known pre-existing interstitial lung disease
- Pathologically documented meningeal carcinomatosis (i.e. cytology (+) lumbar puncture ; radiology reports alone raising this as a possibility, in the absence of true symptomatology, would not constitute an exclusion)
- Presence of brain or subdural metastases, unless local therapy has been completed and use of corticosteroids has been discontinued or the dose has been stable for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment (Pts post SRS can be enrolled earlier as long as their symptoms are stable or improved and they are off steroids)
- 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 2 years and is considered to be cured
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3 or 4 unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to treatment with afatinib.
- Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
- Known or suspected active hepatitis B (Hep B) infection (defined as presence of HepB (surface Antigen) sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier
- Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug
- Treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Trial locations and contacts
1 site in 1 country.
United States1 site
1200.208.10032 Boehringer Ingelheim Investigational Site
Fountain Valley, California
About this study
Official title: An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | Not described Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.
Measured: Up to 98 days
Secondary outcomes (2)
Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)
Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).
Measured: Up to 98 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)
Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.
Measured: Up to 98 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start17 Mar 2016
- Primary completion26 Aug 2016
- Study completion26 Aug 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT02695290
- Sponsor's protocol ID
- 1200.208
- Status last verified
- Sep 2017
- First submitted
- 25 Feb 2016
- Last updated
- 18 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
- ClinicalTrials.gov ID
- NCT02695290
- Acronym / sponsor ID
- 1200.208
- Conditions
- Carcinoma, Non-Small-Cell Lung, ErbB Receptors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
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: Afatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically or cytologically confirmed NSCLC
- Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. The staging is based on American Joint Committee on Cancer (AJCC) Tumor Node Metastatic (TNM) classification of malignant tumors, 7th edition
- Evidence of common EGFR activating mutations (Del 19 and/or L858R)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3
- Adequate organ function, defined as all of the following:
Key exclusion criteria (18 listed)
- Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
- Prior systemic therapy for metastatic or recurrent NSCLC including prior treatment with EGFR targeting small molecules or antibodies. Note: radiotherapy alone and adjuvant/neoadjuvant treatment is not counted as a line of therapy.
- 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:
- i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) Single dose palliative treatment (e.g Stereotactic Radio Surgery(SRS) or Stereotactic Body Radiation Therapy) (SBRT) for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
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 |
|---|---|---|
| Afatinib | Drug | Afatinib |
Primary outcome
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
Time frame: Up to 98 days
Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.
2 secondary outcomes
Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)
Time frame: Up to 98 days
Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)
Time frame: Up to 98 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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
1 site 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 1 site 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 14 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Sep 2017. 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 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 18 Sep 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?
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib (time frame: Up to 98 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 18 Sep 2017.