Iressa v BSC (Best Supportive Care) in First Line NSCLC (INSTEP)

AstraZeneca

Status and phase: Completed; Phase 3; Phase 2

Conditions: NSCLC

Treatments: Other: Placebo; Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259064

D7913C00711

1839IL/0711

Details and patient eligibility

About

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

Enrollment: 216 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed NSCLC
• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
• Not suitable for chemotherapy
• WHO Performance status 2 or 3

Exclusion criteria

• Newly diagnosed CNS mets
• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
• Other co-existing malignancies
• ALT/AST greater than 5 x upper limit of normal
• ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

Gefitinib

Experimental group

Description:

ZD1839 + BSC (best supportive care)

Treatment:

Drug: Gefitinib

Placebo

Placebo Comparator group

Description:

Placebo + BSC (best supportive care)

Treatment:

Other: Placebo