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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma，Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Baseline up to approximately 4 years
Secondary outcomes:
measure: Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1
timeFrame: Baseline up to approximately 4 years
measure: Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1
timeFrame: Baseline up to approximately 4 years
measure: Percentage of Participants Who Were Alive One Year After Study Treatment Initiation
timeFrame: Year 1
measure: Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1
timeFrame: Baseline up to approximately 4 years
measure: Number of EGFR Positive Participants Classified Based on Smoking Status
timeFrame: Day 1
measure: Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations
timeFrame: Day 1
measure: Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples
timeFrame: Baseline up to approximately 4 years
Other outcomes:
Locations:
city: Alba Iulia
country: Romania
facility: County Hospital Alba; Oncology
city: Bucharest
country: Romania
facility: Institute Of Oncology Bucharest; Medical Oncology
city: Bucharest
country: Romania
facility: Spitalul de Boli Cronice Sf. Luca
city: Bucharest
country: Romania
facility: Emergency University Bucharest Hospital; Oncology Department
city: Bucuresti
country: Romania
facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology
city: Cluj-Napoca
country: Romania
facility: Oncology Inst. Cluj-Napoca; Cancer Dept
city: Iasi
country: Romania
facility: Uni Hospital St. Spiridon; Clinica Oncologie-Radiotherapie
city: Timisoara
country: Romania
facility: S.C. Life Search S.R.L; Medical Oncology Clinic
city: Timisoara
country: Romania
facility: ONCOMED - Medical Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: