Phase II Iressa & Carbo/Gem in NSCLC

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Carboplatin; Drug: Gemcitabine; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264498

1839IL/0551

Details and patient eligibility

About

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Non Small cell Lung Cell Lung cancer
• Never received chemotherapy
• Up and about 50% of waking hours

Exclusion criteria

• Spread of lung cancer to the brain
• Low level of white blood cells
• Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Active Comparator group

Description:

Gemcitabine + Carboplatin

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

2

Experimental group

Description:

Gefitinib

Treatment:

Drug: Gefitinib