Non-small Cell Lung CancerPhase 2NCT02747953
Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
A Phase 2 study testing Gilotrif in people with Non-small Cell Lung Cancer, run by Samsung Medical Center.
Trial summary
The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib. The Compassionate Use Programme will also provide additional safety information on gilotrif use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gilotrif
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
- Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
- No further treatment option is available.
- Male and female patients age ≥18 years.
- Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
Who cannot join
- Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
- History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
- Bilirubin ≥1.5 mg/dl
- Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
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- Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
- Pregnancy or breast feeding.
- Pre-existing Interstitial Lung Disease (ILD).
- Patients suitable to be included into afatinib clinical trials
About this study
Official title: An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety information on gilotrif use.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gilotrif
- 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.
GilotrifDrug
Also called Afatinib
50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity.
| Study group | Role | What they receive |
|---|---|---|
| afatinib | Experimental | Not described Receives: Drug: Gilotrif |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747953
- Sponsor's protocol ID
- 2011-09-011
- Status last verified
- Mar 2021
- First submitted
- 22 Oct 2013
- Last updated
- 19 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
- ClinicalTrials.gov ID
- NCT02747953
- Acronym / sponsor ID
- 2011-09-011
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
The Compassionate Use Programme will also provide additional safety information on gilotrif use.
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: Gilotrif |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
- Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
- No further treatment option is available.
- Male and female patients age ≥18 years.
- Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
Key exclusion criteria (10 listed)
- Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
- History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
- Bilirubin ≥1.5 mg/dl
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 |
|---|---|---|
| GilotrifAlso: Afatinib50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity. | Drug | afatinib |
Primary outcome
response rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gilotrif in people with Non-small Cell Lung Cancer, run by Samsung Medical Center.
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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response rate (time frame: 6 months). 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 19 Mar 2021.