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)
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|ClinicalTrials.gov Identifier: NCT01153984|
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma，Non-Small-Cell Lung||Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Erlotinib 150 mg oral doses will be administered daily.
Other Name: Tarceva
- 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 ]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.
- Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1 [ Time Frame: Baseline up to approximately 4 years ]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.
- 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 ]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.
- Percentage of Participants Who Were Alive One Year After Study Treatment Initiation [ Time Frame: Year 1 ]
- Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1 [ Time Frame: Baseline up to approximately 4 years ]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.
- Number of EGFR Positive Participants Classified Based on Smoking Status [ Time Frame: Day 1 ]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'.
- Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations [ Time Frame: Day 1 ]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.
- Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples [ Time Frame: Baseline up to approximately 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153984
|County Hospital Alba; Oncology|
|Alba Iulia, Romania, 510073|
|Institute Of Oncology Bucharest; Medical Oncology|
|Bucharest, Romania, 022338|
|Spitalul de Boli Cronice Sf. Luca|
|Bucharest, Romania, 04195|
|Emergency University Bucharest Hospital; Oncology Department|
|Bucharest, Romania, 050098|
|Institut of Oncology Al. Trestioreanu Bucharest; Oncology|
|Bucuresti, Romania, 022328|
|Oncology Inst. Cluj-Napoca; Cancer Dept|
|Cluj-Napoca, Romania, 400015|
|Uni Hospital St. Spiridon; Clinica Oncologie-Radiotherapie|
|Iasi, Romania, 6600|
|S.C. Life Search S.R.L; Medical Oncology Clinic|
|Timisoara, Romania, 300167|
|ONCOMED - Medical Centre|
|Timisoara, Romania, 300239|
|Study Director:||Clinical Trials||Hoffmann-La Roche|