NCT01130753

Brief Summary

This study propose neoadjuvant chemotherapeutic role by erlotinib.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

3.9 years

First QC Date

May 17, 2010

Last Update Submit

May 29, 2013

Conditions

Lung NeoplasmsErlotinibNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic down-staging

    36 months

Secondary Outcomes (4)

  • Response rate

    36 months

  • Toxicity

    36 months

  • Progression free survival

    36 months

  • Overall survival

    36 months

Interventions

ErlotinibDRUG

Erlotinib 150mg per day for 8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 26, 2010

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

KR(1)