- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01153984
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations (BIOTEC)
March 1, 2017 updated by: Hoffmann-La Roche
Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment.
The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Study Overview
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alba Iulia, Romania, 510073
- County Hospital Alba; Oncology
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Bucharest, Romania, 050098
- Emergency University Bucharest Hospital; Oncology Department
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Bucharest, Romania, 022338
- Institute Of Oncology Bucharest; Medical Oncology
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Bucharest, Romania, 04195
- Spitalul de Boli Cronice Sf. Luca
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Bucuresti, Romania, 022328
- Institut of Oncology Al. Trestioreanu Bucharest; Oncology
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Cluj-Napoca, Romania, 400015
- Oncology Inst. Cluj-Napoca; Cancer Dept
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Iasi, Romania, 6600
- Uni Hospital St. Spiridon; Clinica Oncologie-Radiotherapie
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Timisoara, Romania, 300239
- ONCOMED - Medical Centre
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Timisoara, Romania, 300167
- S.C. Life Search S.R.L; Medical Oncology Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
- Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than or equal to (≥) 12 weeks
- Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
- Adequate hematological , liver and renal function
Exclusion Criteria:
- Known hypersensitivity to erlotinib or any of its excipients
- Squamous non-small cell or small cell tumors or absence of histological report
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
- Prior exposure to inhibitors of EGFR
- Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
- Radical radiotherapy with curative intent within 28 days prior to enrollment
- Any active non-controlled systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erlotinib
Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
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Erlotinib 150 mg oral doses will be administered daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: Baseline up to approximately 4 years
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PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first.
Participants without event were censored at the date of the last tumor assessment where non-progression was documented.
If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
Analysis was performed using Kaplan-Meier method.
PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
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Baseline up to approximately 4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1
Time Frame: Baseline up to approximately 4 years
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Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded.
Participants without progression were censored at the date of last tumor assessment where non-progression was documented.
PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
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Baseline up to approximately 4 years
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Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1
Time Frame: Baseline up to approximately 4 years
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CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline.
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Baseline up to approximately 4 years
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Percentage of Participants Who Were Alive One Year After Study Treatment Initiation
Time Frame: Year 1
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Year 1
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Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1
Time Frame: Baseline up to approximately 4 years
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PD was assessed using RECIST v1.1.
PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Percentage of participants by localization of PD were reported.
Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial.
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Baseline up to approximately 4 years
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Number of EGFR Positive Participants Classified Based on Smoking Status
Time Frame: Day 1
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Participants were asked: "Have you smoked at least 100 cigarettes in your entire life?" and "Do you now smoke cigarettes every day, some days, or not at all?" Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker.
Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'.
Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'.
Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'.
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Day 1
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Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations
Time Frame: Day 1
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Participants with NSCLC have tumor associated with EGFR mutations.
These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain.
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Day 1
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Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples
Time Frame: Baseline up to approximately 4 years
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Baseline up to approximately 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 29, 2010
First Posted (Estimate)
June 30, 2010
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- ML22606
- 2009-017063-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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