Carcinoma, Non-Small-Cell LungPhase 2NCT00796549
BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients
A Phase 2 study testing BiBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 13 sites in Italy.
Trial summary
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme: Forty (40)… 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?
- BiBW 2992
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesItaly
- Study dates
- Dec 2008to May 2012
- Phase
- Phase 2
- 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
- Male and female patients aged >18 years.
- Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with pleural effusion) or Stage IV and histopathological classification of adeno- or bronchoalveolar carcinoma (BAC).
- Increased EGFR gene copy number assessed by FISH analysis. After signed informed consent, positive result to EGFR FISH determination is mandatory to proceed to other screening assessments.
- At least one tumour lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as more or same 20 mm using conventional techniques or moro or same 10 mm with spiral CT scan.
- Patients not previously exposed to chemotherapy for NSCLC (1st line patients, 40 in total; for these subjects adjuvant chemotherapy is allowed if at least 12 months elapsed since last course of treatment), or patients with relapse after one systemic treatment (2nd line patients, 30 in total; if less than 12 months elapsed since adjuvant chemotherapy, patients are 2nd line ones, as adjuvant chemotherapy must be considered a line of treatment).
- Life expectancy of at least three (3) months.
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0, 1 or 2.
- Written informed consent that is consistent with ICH-GCP guidelines.
Who cannot join
- More than two (2) prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic NSCLC, included adjuvant chemotherapy if relapse occurred less than 12 months before
- Previous treatment with erlotinib (Tarceva®), gefitinib (Iressa®) or any other EGFR inhibiting small molecule or antibody.
- Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
- Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
- Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn disease, malabsorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
- Patients who have any other life-threatening illness or organ system dysfunction which, in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
Show all 14Show fewer
- Other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer and in situ cervical cancer).
- Radiotherapy within the past 2 weeks prior to treatment with the trial drug.
- Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents).
- Patients with known HIV, active hepatitis B or active hepatitis C.
- Known or suspected active drug or alcohol abuse.
- 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 trial.
- Pregnancy or breast feeding.
- Patients unable to comply with the protocol.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
1200.40.39011 Boehringer Ingelheim Investigational Site
Arezzo
1200.40.39007 Boehringer Ingelheim Investigational Site
Aviano (PN)
1200.40.39013 Boehringer Ingelheim Investigational Site
Faenza (RA)
1200.40.39003 Boehringer Ingelheim Investigational Site
Genova
1200.40.39010 Boehringer Ingelheim Investigational Site
Livorno
1200.40.39012 Boehringer Ingelheim Investigational Site
Lugo (RA)
1200.40.39008 Boehringer Ingelheim Investigational Site
Modena
1200.40.39005 Boehringer Ingelheim Investigational Site
Monza (MI)
1200.40.39006 Boehringer Ingelheim Investigational Site
Padova
1200.40.39002 Boehringer Ingelheim Investigational Site
Perugia
1200.40.39004 Boehringer Ingelheim Investigational Site
Prato
1200.40.39009 Boehringer Ingelheim Investigational Site
Ravenna
1200.40.39001 Boehringer Ingelheim Investigational Site
Rozzano (MI)
About this study
Official title: A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:
- Forty (40) 1st line patients
- Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BiBW 2992
- 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.
BiBW 2992Drug
BIBW 2992 in EGFR FISH positive NSCLC patients
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | BIBW 2992 in EGFR FISH positive NSCLC patients Receives: Drug: BiBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Best Objective Response
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
Measured: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Secondary outcomes (10)
Number of Participants With Objective Response (OR) Categorized by Time
Cumulative number of participants with objective response by time points with responders.
Measured: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Duration of Confirmed Objective Response (OR)
Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).
Measured: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Percentage of Participants With Disease Control (DC)
Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.
Measured: Every 8 weeks until last response assessment 28NOV12
Duration of Confirmed Disease Control
Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.
Measured: Every 8 weeks until last response assessment 28NOV12
Progression Free Survival (PFS) Time
Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
Measured: Every 8 weeks until last response assessment 28NOV12
Overall Survival (OS) Time
Overall survival time is defined as time from the date of start of treatment to the date of death.
Measured: Baseline until last vital status assessment 17JUN13
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)
Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
Measured: Day 15
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.
Measured: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.
There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF).
Measured: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :
0 : Fully active, able to carry on all pre-disease performance without restriction.
- : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- : Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
- : Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- : Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- : Dead.
Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included.
Measured: End Of Treatment, up until 190 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT00796549
- Sponsor's protocol ID
- 1200.40
- Other IDs
- 2008-001264-37, 2008
- Status last verified
- Jul 2014
- First submitted
- 21 Nov 2008
- Last updated
- 22 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00796549
- Acronym / sponsor ID
- 1200.40
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2012 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:
- Forty (40) 1st line patients
- Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BiBW 2992BIBW 2992 in EGFR FISH positive NSCLC patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients aged >18 years.
- Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with pleural effusion) or Stage IV and histopathological classification of adeno- or bronchoalveolar carcinoma (BAC).
- Increased EGFR gene copy number assessed by FISH analysis. After signed informed consent, positive result to EGFR FISH determination is mandatory to proceed to other screening assessments.
- At least one tumour lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as more or same 20 mm using conventional techniques or moro or same 10 mm with spiral CT scan.
- Patients not previously exposed to chemotherapy for NSCLC (1st line patients, 40 in total; for these subjects adjuvant chemotherapy is allowed if at least 12 months elapsed since last course of treatment), or patients with relapse after one systemic treatment (2nd line patients, 30 in total; if less than 12 months elapsed since adjuvant chemotherapy, patients are 2nd line ones, as adjuvant chemotherapy must be considered a line of treatment).
Key exclusion criteria (14 listed)
- More than two (2) prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic NSCLC, included adjuvant chemotherapy if relapse occurred less than 12 months before
- Previous treatment with erlotinib (Tarceva®), gefitinib (Iressa®) or any other EGFR inhibiting small molecule or antibody.
- Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
- Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
- Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn disease, malabsorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
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 |
|---|---|---|
| BiBW 2992BIBW 2992 in EGFR FISH positive NSCLC patients | Drug | BIBW 2992 |
Primary outcome
Percentage of Participants With Best Objective Response
Time frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
10 secondary outcomes
Number of Participants With Objective Response (OR) Categorized by Time
Time frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Duration of Confirmed Objective Response (OR)
Time frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Percentage of Participants With Disease Control (DC)
Time frame: Every 8 weeks until last response assessment 28NOV12
Duration of Confirmed Disease Control
Time frame: Every 8 weeks until last response assessment 28NOV12
Progression Free Survival (PFS) Time
Time frame: Every 8 weeks until last response assessment 28NOV12
Overall Survival (OS) Time
Time frame: Baseline until last vital status assessment 17JUN13
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)
Time frame: Day 15
Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder
Time frame: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction
Time frame: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: End Of Treatment, up until 190 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BiBW 2992 in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 13 sites in Italy.
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 8 inclusion and 14 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 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. 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 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?
Yes. Results are posted in the registry (first posted 17 Oct 2013). 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 With Best Objective Response (time frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.). 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 22 Jul 2014.