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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Iressa v BSC (Best Supportive Care) in First line NSCLC

NCT ID

Therapeutic Area

Research Site

A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

Arms	Assigned Interventions
Experimental: Gefitinib ZD1839 + BSC (best supportive care)	-
Placebo Comparator: Placebo Placebo + BSC (best supportive care)	-

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

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Study design

Verification:

Sponsors

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Inclusion Criteria

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Documents available

CSR-1839IL-0711.pdf

Trial Results Summaries

Contacts

Contact

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Principal Investigator