Clinical trial NCT00234468: Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
Official title: A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non Small Cell Lung Carcinoma
Keywords: Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy


Eligibility criteria: Inclusion Criteria:

* Histologically Confirmed Non Small Cell Lung Cancer.
* Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
* Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
* Response to combined therapy

Exclusion Criteria:

* No previous treatment with ZD1839 or any other EGFR-targeted therapy
* No progressive disease after combined therapy for locally advanced NSCLC
* No presence of metastatic disease
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity from previous anticancer therapy.

Primary outcomes:
measure: Time to progression (2 years after Last patient in)
Secondary outcomes:
measure: Modalities of relapse or progression (2 years after Last patient in)
measure: Overall survival (2 years after Last patient in)
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Campobasso
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Chieti
country: Italy
facility: Research Site
city: Cosenza
country: Italy
facility: Research Site
city: Della Fratte
country: Italy
facility: Research Site
city: Emilia
country: Italy
facility: Research Site
city: Fano
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Forli
country: Italy
facility: Research Site
city: Frattamaggiore
country: Italy
facility: Research Site
city: Livorno
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Potenza
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Rimini
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Taormina
country: Italy
facility: Research Site
city: Venezia-Mestre
country: Italy
facility: Research Site
Study officials:
affiliation: Bologna Italy
name: Lucio Crino, MD
role: PRINCIPAL_INVESTIGATOR
References: