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Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations

Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations - Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012725
Enrollment
15
Registered
2014-01-02
Start date
2014-01-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Patients will receive daily erlotinib at 150mg/day for six weeks. The patients with responsive disease considered to be technically resectable will undergo surgical resection.

Sponsors

Department of Thoracic Surgery, Tsukuba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-small cell lung cancer 2) cStageIII-N2 3) Activating EGFR mutations 4) Without previously treatment for lung cancer 5) Has measurable by RECIST (ver. 1.1) criteria 6) ECOG performance status 0-1 7) Age >= 20 years 8) Adequate organ function Absolute neutrophil count (ANC) >= 1,500/mm3 Platelets >= 100000/mm3 Hemoglobin >= 9.0g/dL AST and ALT <= 2.5 x ULN Total bilirubin <= 1.5 x ULN Serum creatinine <= 1.5 x ULN SpO2 >= 90% 9) Life expectancy more than 3 months 10) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Active lung disease such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or medicine-induced pneumonitis 2) Prior exposure to agents directed at the HER axis (e.g. erlotinib, gefetinib, cetuximab, trastuzumab) 3) Gastrointestinal abnormalities, including active peptic ulcer or inflammatory bowel disease 4) Active ophthalmologic diseases (e.g. Sjogrens) 5) Neurological symptoms of spinal cord compression 6) Uncontrolled infections 7) History of severe heart disease 8) Serious medical complications 9) Multiple primary cancer 10) Serious psychiatric illness or psychological symptom 11) Women who are pregnant, lactating or with childbearing potential 12) Ineligible based on decision of an investigator.

Design outcomes

Primary

MeasureTime frame
Radical resection rate

Countries

Japan

Contacts

Public ContactShinji Kikuchi

Tsukuba University Hospital Department of Thoracic Surgery

S.kikuchi@md.tsukuba.ac.jp029-853-5600(90169)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026