Afatinib Plus Nimotuzumb for NSCLC
A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
1 other identifier
interventional
50
1 country
1
Brief Summary
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFebruary 25, 2014
February 1, 2014
2 years
May 21, 2013
February 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 weeks
Study Arms (1)
afatinib + nimotuzumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2016
Last Updated
February 25, 2014
Record last verified: 2014-02