Carcinoma, Non-Small-Cell LungPhase 4NCT02208843
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
A Phase 4 study testing Afatinib in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 21 sites in 7 countries.
Trial summary
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate… 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
- 60 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 2 Oct 2014to 13 Jun 2017
- 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 confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
- Measureable disease according to RECIST 1.1.
- Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Adequate organ function.
Who cannot join
- More than one line of prior therapy for disease.
- Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
- Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
- Known pre-existing interstitial lung disease.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Romania4 sites
Braila County Emergency Hospital, Medical Oncology
Brăila, 810303
Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
Bucharest, 022328
Sf. Nectarie Oncology Center, Craiova
Craiova, 200347
Regional Oncology Institute of Iasi, Medical Oncology
Iași, 700483
Serbia4 sites
Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
Belgrade, 11000
Clinical Center of Serbia
Belgrade, 11129
Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
Kamenitz, 21204
Clinical Center Kragujevac
Kragujevac, 34000
Thailand4 sites
Wattanosoth Hospital
Bangkok, 10310
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rajavithi Hospital
Bangkok, 10400
Songklanagarind Hospital
Songkhla, 90110
Egypt3 sites
Clinical Research Center, Alexandria University Hospital
Alexandria, 21131
National Cancer Institute, Cairo University
Cairo, 11796
Kasr Al Ainy Hospital
Cairo, 12311
Poland3 sites
University Clinical Center, Gdansk
Gdansk, 80-952
Specialist Hospital, Szczecin-Zdunowo
Szczecin-Zdunowo, 70-891
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
Warsaw, 02-781
Philippines2 sites
Baguio General Hospital and Medical Center
Baguio City, 2600
St. Luke's Medical Center
City of Taguig, 1634
About this study
Official title: An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
- 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
Afatinib tablet once daily until progression
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | Afatinib tablet once daily until progression Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
Measured: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Secondary outcomes (2)
Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
Measured: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study start2 Oct 2014
- Primary completion17 May 2017
- Study completion13 Jun 2017
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
- 60 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
- NCT02208843
- Sponsor's protocol ID
- 1200.217
- Other IDs
- 2014-001077-14, 2014
- Status last verified
- Jun 2018
- First submitted
- 4 Aug 2014
- Last updated
- 17 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT02208843
- Acronym / sponsor ID
- 1200.217
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2014 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
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 tablet once daily until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
- Measureable disease according to RECIST 1.1.
- Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
Key exclusion criteria (4 listed)
- More than one line of prior therapy for disease.
- Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
- Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
- Known pre-existing interstitial lung disease.
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 tablet once daily until progression | Drug | Afatinib |
Primary outcome
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
2 secondary outcomes
Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- 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
21 sites in 7 countries: 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, run by Boehringer Ingelheim at 21 sites in 7 countries.
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 6 inclusion and 4 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Romania, Serbia, Thailand, Egypt, Poland and 2 more countries. 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 17 Dec 2018). 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?
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1 (time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 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 17 Dec 2018.