Carcinoma, Non-Small-Cell LungPhase 2NCT01003899
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
A Phase 2 study testing afatinib (BIBW 2992) in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 3 sites in South Korea.
Trial summary
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- afatinib (BIBW 2992)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Oct 2009to Nov 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
- Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
- A known wild-type EGFR status
- Patients 18 years of age or older
Who cannot join
- More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
- Prior treatment with EGFR targeting small molecules or antibodies
- Radiotherapy or surgery within 4 weeks prior to study entry
- Active brain metastasis
- Known pre-existing interstitial lung disease
- History or presence of clinically relevant cardiovascular abnormalities
Show all 12Show fewer
- Cardiac left ventricular function with resting ejection fraction of less than 50%
- Absolute neutrophil count[ANC] < 1,500/mm3
- Platelet count <100,000/mm3
- Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal
- Women of childbearing 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
1200.72.8201 Boehringer Ingelheim Investigational Site
Seoul
1200.72.8202 Boehringer Ingelheim Investigational Site
Seoul
1200.72.8203 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- afatinib (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.
afatinib (BIBW 2992)Drug
afatinib (BIBW 2992) po QD
| Study group | Role | What they receive |
|---|---|---|
| afatinib (BIBW 2992) | Experimental | patient to receive afatinib(BIBW 2992) po QD in an open-label manner Receives: Drug: afatinib (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 1.1).
Measured: Baseline till progression or death
Secondary outcomes (5)
Percentage of Participants With Disease Control (DC)
Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.
Measured: Baseline till progression or death
Progression Free Survival (PFS) Time
PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death
Measured: Baseline till end of study or death
Duration of Disease Control (DC)
Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).
Measured: Baseline till progression or death
Time to OR
The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.
Measured: Baseline till progression or death
Duration of OR
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Measured: Baseline till progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01003899
- Sponsor's protocol ID
- 1200.72
- Status last verified
- Aug 2013
- First submitted
- 28 Oct 2009
- Last updated
- 31 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ahn MJ, Kim SW, Cho BC, Ahn JS, Lee DH, Sun JM, Massey D, Kim M, Shi Y, Park K. Phase II study of Afatinib as third-line treatment for patients in Korea with stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR. Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27.
PubMed 24868099
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR
- ClinicalTrials.gov ID
- NCT01003899
- Acronym / sponsor ID
- 1200.72
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- First posted
- 29 Oct 2009 (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.
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| afatinib (BIBW 2992) | Experimental | Drug: afatinib (BIBW 2992)patient to receive afatinib(BIBW 2992) po QD in an open-label manner |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
- Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
- A known wild-type EGFR status
- Patients 18 years of age or older
Key exclusion criteria (12 listed)
- More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
- Prior treatment with EGFR targeting small molecules or antibodies
- Radiotherapy or surgery within 4 weeks prior to study entry
- Active brain metastasis
- 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 |
|---|---|---|
| afatinib (BIBW 2992)afatinib (BIBW 2992) po QD | Drug | afatinib (BIBW 2992) |
Primary outcome
Percentage of Participants With Best Objective Response
Time frame: Baseline till progression or death
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
5 secondary outcomes
Percentage of Participants With Disease Control (DC)
Time frame: Baseline till progression or death
Progression Free Survival (PFS) Time
Time frame: Baseline till end of study or death
Duration of Disease Control (DC)
Time frame: Baseline till progression or death
Time to OR
Time frame: Baseline till progression or death
Duration of OR
Time frame: Baseline till progression or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24868099Ahn MJ, Kim SW, Cho BC, Ahn JS, Lee DH, Sun JM, Massey D, Kim M, Shi Y, Park K. Phase II study of Afatinib as third-line treatment for patients in Korea with stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR. Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27.
- Related InfoLink provided by the sponsor.
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
3 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 afatinib (BIBW 2992) in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 3 sites in South Korea.
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 4 inclusion and 12 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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: Baseline till progression or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003899, which also lists 1 linked publication.
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 31 Dec 2013.