Completed

A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy

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What is being tested

Tarceva (Trademark) (erlotinib HCl, OSI-774)

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorOSI Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 5, 2003

Actual date on which the first participant was enrolled.

Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Official TitleA Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy 
NCT00072631
Principal SponsorOSI Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

43 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

Inclusion Criteria: * Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological). * Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer. * Measurable disease per RECIST criteria. * Adequate bone marrow, hepatic and renal function. Exclusion Criteria: * Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years. * Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days. * Known hypersensitivity to minocycline. * History of serious cardiac disease that is not controlled. * Serious eye conditions. * Prior treatment with inhibitors of EGFR of any kind.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institute for Drug Development Cancer Therapy and Research Center

San Antonio, United StatesSee the location
CompletedOne Study Center