Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Phase 2

Completed

• Conditions: Adenocarcinoma; Non-small Cell Lung Cancer
• Interventions: Drug: Erlotinib

• Registration Number: NCT00137839
• Lead Sponsor: Pasi A. Janne, MD, PhD

Brief Summary

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Detailed Description

Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Primary Completion: 2008-11
• Study Completion: 2019-07
• Results First Submitted: 2019-10-08
• Results First Submitted QC: 2019-11-15
• Results First Posted: 2019-11-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-07
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Female
• Diagnosis of adenocarcinoma of the lung
• Patient has had at least one core biopsy of her tumor
• Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
• Stage four (IV) or three (III) B non-small cell lung cancer
• Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
• Three or more weeks since last radiation therapy
• Three or more weeks since last major surgery
• Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
• Life expectancy of 8 weeks or more
• Blood tests that show kidneys, liver and bone marrow to be working adequately
• Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study

Exclusion Criteria

• Prior exposure to Tarceva (OSI-774, erlotinib)
• Uncontrolled central nervous system problems
• Prior chemotherapy regimen
• Difficulty swallowing
• A disease or disorder that interferes with ability to digest and absorb food
• Incomplete healing of previous oncologic or other major surgery
• Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
• Pregnant or breast feeding
• A medical condition that could make it unsafe for patient to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib	Erlotinib	Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.	ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Name	Time	Method
Overall Survival by EGFR Mutation Status	In this study cohort, participants were followed for survival up to 155 months.	OS is defined as the time from study entry to death or date last known alive.
Overall Response Rate (ORR) by EGFR Mutation Status	In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.	ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
Overall Survival (OS)	In this study cohort, participants were followed for survival up to 155 months.	OS is defined as the time from study entry to death or date last known alive.

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States