First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia (IPASS)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Gefitinib; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322452

D791AC00007

Iressa Pan Asian Study (IPASS)

Details and patient eligibility

About

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.

Enrollment: 1,329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
• Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)

Exclusion criteria

• Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
• Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,329 participants in 2 patient groups

1

Experimental group

Description:

gefitinib

Treatment:

Drug: Gefitinib

2

Active Comparator group

Description:

Carboplatin/Paclitaxel

Treatment:

Drug: Carboplatin

Drug: Paclitaxel