Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
1 other identifier
interventional
26
1 country
1
Brief Summary
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2012
Longer than P75 for phase_2
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
First Submitted
Initial submission to the registry
November 4, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedApril 6, 2022
April 1, 2022
10 years
November 4, 2011
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free survival
Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
every 8 week
Secondary Outcomes (3)
Response rate
every 4 weeks
Overall Survival Rate
every 3months, until death
Toxicity profile
Every 4 weeks
Study Arms (1)
Study arm
EXPERIMENTALNeo-adjuvant Erlotinib treatment arm.
Interventions
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed stage II \& IIIA non-small cell lung cancer
- EGFR exon 19 or 21 mutations
- Age ≥ 18 years and ECOG performance 0\~1
- Has measurable lesion by RECIST 1.1
- No previous chemotherapy or radiation therapy
- Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr \< 1 x UNL or creatinine clearance \> 60 ml/min, Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL
- Written informed consent form
You may not qualify if:
- Previous chemotherapy or radiation therapy
- Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
- Known allergic history of erlotinib
- Interstitial lung disease or fibrosis on chest radiogram
- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Center, Korealead
- Hoffmann-La Rochecollaborator
Study Sites (1)
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji-Youn Han, M.D. PhD.
National Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2011
First Posted
November 11, 2011
Study Start
January 1, 2012
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
April 6, 2022
Record last verified: 2022-04