Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

Study summary

The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTarceva (Erlotinib)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 28, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Weill Medical College of Cornell University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Weill Medical College of Cornell University
Interventions being studied: Drug: Tarceva (Erlotinib)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Study topics

Before surgery (neoadjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical resection
Ambulatory and capable of all self-care but may be unable to carry out any work activities.
Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell medical center for purposes of volumetric measurements.
Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.
18 years and older.
Women of child-bearing potential must be taking adequate contraceptive precautions prior to study entry and for the duration of study participation. A negative serum or urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen or agree to abstain from heterosexual intercourse while taking study drug and for 30 days following the last dose of study drug.

Reasons someone may not be able to joinExclusion criteria

Cannot be on any other anti-cancer treatment during this study.
Prior treatment with any EGFR inhibitor.
Patients who had prior treatment with chemotherapy or radiation for this disease.
Other active cancers.
Tumors with a mixed histology of small cell and non-small cell carcinoma as well as patients with pulmonary carcinoid tumors.
Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel disease.
Hypersensitivity to compounds similar in chemical composition to Tarceva®.
Active infection or serious underlying medical conditions which would impair protocol treatment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Weill Medical College of Cornell UniversityNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 28, 2018. Always confirm current availability with the study team.

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