Trial information
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Status: Recruiting
Protocol number: ML17915
Sponsor: Roche Farma S.A.
Company division: Pharmaceutical
Official Scientific 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
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, and the target sample size is 500+ individuals.
Target sample size is 1049.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. Efficacy: Clinical benefit (time to progression).
Key secondary outcomes: 1. Efficacy: Rates of partial response, complete response, and stable disease. Overall survival. Safety: Adverse events
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2004
Trial registration date: 11/01/2005
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Spain
- Alcorcon
- Alcoy
- Algeciras
- Alicante
- Almería
- Avila
- Badajoz
- Badalona
- Barakaldo
- Barcelona
- Baza
- Bilbao
- Burgos
- Cádiz
- Castellon
- Córdoba
- Don Benito
- El Palmar Murcia
- Elche
- Ferrol
- Girona
- Granada
- Granollers
- Huelva
- Ibiza
- Jaen
- La Coruna
- La Laguna
- Las Palmas de Gran Canaria
- Leon
- Lleida
- Lugo
- Madrid
- Malaga
- Manresa
- Mataro
- Merida
- Murcia
- Navarra
- Orense
- Palencia
- Palma de Mallorca
- Pamplona
- Sabadell
- Sagunto
- Salamanca
- San Sebastian
- Sant Coloma Gramenet
- Sant Pere De Ribes
- Santa Cruz de Tenerife
- Santander
- Segovia
- Sevilla
- Terrassa
- Torrevieja
- Valencia
- Valladolid
- Vic
- Vigo
- Zaragoza
