Clinical trial NCT01996332: A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 1805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced or metastatic NSCLC (Stage IIIB or IV);
* not a candidate for curative surgery or radical chemotherapy;
* no brain metastases, or clinically stable metastases for \>=2 months.

Exclusion Criteria:

* radiotherapy over the previous 2 weeks;
* weight loss \>10% in the previous 6 weeks.

Primary outcomes:
measure: Time to Disease Progression or Death by Line of Treatment
timeFrame: Baseline, every 6-8 weeks up to 3 years until disease progression or death
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Benefit by Line of Treatment
timeFrame: Baseline, every 6-8 weeks up to 3 years or until death
measure: Overall Survival (OS) by Line of Treatment
timeFrame: Baseline, every 6-8 weeks up to 3 years, or until death
Other outcomes:
Locations:
city: Alcoy
country: Spain
state: Alicante
city: Elche
country: Spain
state: Alicante
city: Almería
country: Spain
state: Almeria
city: Don Benito
country: Spain
state: Badajoz
city: Merida
country: Spain
state: Badajoz
city: Badalona
country: Spain
state: Barcelona
city: Granollers
country: Spain
state: Barcelona
city: Manresa
country: Spain
state: Barcelona
city: Mataro
country: Spain
state: Barcelona
city: Sabadell, Barcelona
country: Spain
state: Barcelona
city: Sant Coloma Gramenet
country: Spain
state: Barcelona
city: Sant Pere de Ribes
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: VIC
country: Spain
state: Barcelona
city: Algeciras
country: Spain
state: Cadiz
city: Cádiz
country: Spain
state: Cadiz
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Puerto Real
country: Spain
state: Cadiz
city: Santander
country: Spain
state: Cantabria
city: Torrevieja
country: Spain
state: Cantabria
city: Baza
country: Spain
state: Granada
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Ibiza
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Palma De Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Ferrol
country: Spain
state: La Coruña
city: La Coruna
country: Spain
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Alcorcon
country: Spain
state: Madrid
city: Cartagena
country: Spain
state: Murcia
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: Vigo
country: Spain
state: Pontevedra
city: La Laguna
country: Spain
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
state: Tenerife
city: Sagunto
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Avila
country: Spain
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Caceres
country: Spain
city: Castellon
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Huelva
country: Spain
city: Jaen
country: Spain
city: La Coruña
country: Spain
city: Leon
country: Spain
city: Lerida
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Murcia
country: Spain
city: Navarra
country: Spain
city: Orense
country: Spain
city: Palencia
country: Spain
city: Salamanca
country: Spain
city: Segovia
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: