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CompletedNCT01130753Updated May 30, 2013

Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

A Phase 2 interventional study of Erlotinib in Lung Neoplasms, Erlotinib and Neoadjuvant Therapy, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study propose neoadjuvant chemotherapeutic role by erlotinib.

Read the detailed description

It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.

Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.

So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.

02

Conditions studied

  • Lung Neoplasms
  • Erlotinib
  • Neoadjuvant Therapy

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 43 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer
  • Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women
  • 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

Exclusion Criteria:

  • Pulmonary carcinoid tumor
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Interventions

  • DrugErlotinib

    Erlotinib 150mg per day for 8 weeks

06

What researchers measure

Primary outcomes

  1. Pathologic down-staging

    Time frame: 36 months

Secondary outcomes

  1. Response rate

    Time frame: 36 months

  2. Toxicity

    Time frame: 36 months

  3. Progression free survival

    Time frame: 36 months

  4. Overall survival

    Time frame: 36 months

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01130753
Lead sponsor
Samsung Medical Center
Responsible party
Keunchil Park (Principal investigator, Samsung Medical Center) — Principal investigator
First posted
May 26, 2010
Start date
Jan 2007
Primary completion
Dec 2010
Completion
Dec 2012
Last update
May 30, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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