NSCLCPhase 1/2NCT01861223
Afatinib Plus Nimotuzumb for NSCLC
A Phase 1/2 study testing afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) in people with NSCLC, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to May 2016
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of stage IIIB or IV NSCLC
- Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
- Disease progression on treatemtn with gefitinib or erlotinib within 30 days
- Biopsy on disease progression
- Age ≥20 years
- ECOG performance status of 0, 1, or 2
- Measurable disease by the criteria of RECIST 1.1
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 45 mL/min
Who cannot join
- Known interstitial lung disease
- Prior treatment with EGFR targeting antibodies or BIBW 2992
- Prior three or more lines of chemotherapy for advanced NSCLC
- Significant bowel disease impairing drug absorption
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Myung-Ju Ahn
Jong-Mu Sun
About this study
Official title: A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.
- Conditions
- NSCLC
- Being tested
- afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)
- Keywords
- acquired resistance, gefitinib, erlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| afatinib + nimotuzumab | Experimental | Not described Receives: Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose
To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861223
- Sponsor's protocol ID
- 2012-11-087-007
- Status last verified
- Feb 2014
- First submitted
- 21 May 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
- ClinicalTrials.gov ID
- NCT01861223
- Acronym / sponsor ID
- 2012-11-087-007
- Conditions
- NSCLC
- Keywords
- acquired resistance, gefitinib, erlotinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 23 May 2013 (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.
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| afatinib + nimotuzumab | Experimental | Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of stage IIIB or IV NSCLC
- Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
- Disease progression on treatemtn with gefitinib or erlotinib within 30 days
- Biopsy on disease progression
- Age ≥20 years
Key exclusion criteria (6 listed)
- Known interstitial lung disease
- Prior treatment with EGFR targeting antibodies or BIBW 2992
- Prior three or more lines of chemotherapy for advanced NSCLC
- Significant bowel disease impairing drug absorption
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
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 (30 or 40mg) + nimotuzumab (100 or 200mg) | Drug | afatinib + nimotuzumab |
Primary outcome
Maximal tolerated dose
Time frame: 4 weeks
To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) in people with NSCLC, run by Samsung Medical Center at 1 site 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Feb 2014. 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ju Ahn (822-3410-3459, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal tolerated dose (time frame: 4 weeks). 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 25 Feb 2014.