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Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

UnknownPhase 2

Sponsor: National Cancer Center, Korea

Conditions: NSCLC Stage II, NSCLC, Stage IIIA

Interventions: Erlotinib

Countries: South Korea

This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (1)

Goyang-si, Gyeonggi-do, South Korea