Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer

Conditions

• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib Hydrochloride — DRUG
  Given PO
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo thoracotomy
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

This phase II trial studies how well erlotinib hydrochloride works before surgery in treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key Dates

First listed

May 20, 2013

Start date

Nov 30, 2013

Status verified

Jun 2020

Primary completion

Aug 31, 2017

Completion

Aug 31, 2017

Study Design

Enrollment

3 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (erlotinib hydrochloride and thoracotomy)
  Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.

Primary Outcome Measure

Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy [ Time Frame: 3 years 9 months ]

Locations (3)

Find similar trials in New York, NY