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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 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.

Phase II  Iressa & Carbo/Gem in NSCLC

Research Site

A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression

Age Continuous

Gender, Male/Female

Race, Customized

No analysis of the efficacy results was performed as the study was prematurely terminated with only 35 out of the planned 122 subjects randomized.
Serious and Other adverse event data for Periods 1 and 2 were combined by treatment for this report.

Progression free survival (PFS)

Randomized Treatment

Crossover Treatment

Following enrolment there was a 7 - 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.
Following objective disease progression on randomized treatment (Period 1), subjects were encouraged to crossover to the other treatment (Period 2).

Arms	Assigned Interventions
Active Comparator: 1 Gemcitabine + Carboplatin	Drug: Gemcitabine intravenous injection Other Name: Gemzar Drug: Carboplatin intravenous injection Other Name: CBDCA
Experimental: 2 Gefitinib	Drug: Gefitinib oral tablet Other Name: IRESSA Other Name: ZD1839

Phase II Iressa & Carbo/Gem in NSCLC

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

US and Canada only

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=220&filename=CSR-1839IL-0551.pdf

CSR-1839IL-0551.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator