Neoplasms

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

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Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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Erlotinib Hydrochloride

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Enzyme Inhibitors

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Tarceva (erlotinib)

Joaquin Casal, MD

Joquin Casal, MD

A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.

STUDY OBJECTIVES

Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva

Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

Grupo Gallego de Cancer de Pulmon

Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Tarceva (Erlotinib)

Nasser K Altorki, MD

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.

Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after failure of at least one chemotherapy treatment. However, it is not approved for the first treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.

Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib) at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be offered to patients who had at least a 50% (half) decrease in size of their tumor after treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their surgery.

Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II. Patients who receive post-operative chemotherapy will begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery. Follow-up for recurrence and survival will continue for 2 years.

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

A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer

High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.

Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.

Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.

Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.

Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites.

Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites.

OSI Pharmaceuticals

Weill Medical College of Cornell University

Erlotinib

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Nasser Altorki, MD

One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.

Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.

Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.

Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Tarceva (Erlotinib): Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer	NCT00466284	Non-Small Cell ...	Tarceva (erloti...	18 Years - 90 Years	Grupo Gallego de Cancer de Pulmon
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer	NCT00385996	Carcinoma, Non-...	Tarceva (Erloti...	18 Years - 85 Years	Weill Medical College of Cornell University
Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer	NCT00385996	Carcinoma, Non-...	Tarceva (Erloti...	18 Years - 85 Years	Weill Medical College of Cornell University

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