Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-Small-Cell Lung Cancer, NSCLC, Lung Cancer
Brief summary
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.
Interventions
DRUGGefitinib
oral tablet
DRUGGemcitabine
intravenous injection
DRUGCarboplatin
intravenous injection
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Date of randomization to earliest date of objective disease progression | 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 |
Countries
Canada
Participant flow
Recruitment details
Patients were recruited at 2 Canadian cancer clinics between October 2004 and October 2007.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator Gemcitabine + Carboplatin | 17 |
| Experimental Gefitinib | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Crossover Treatment | Death | 1 | 3 |
| Crossover Treatment | Objective disease progression | 4 | 5 |
| Crossover Treatment | Study closure | 0 | 1 |
| Crossover Treatment | Withdrawal by Subject | 1 | 0 |
| Randomized Treatment | Death | 0 | 3 |
| Randomized Treatment | Incorrectly randomized | 1 | 0 |
| Randomized Treatment | Objective disease Progression | 13 | 14 |
| Randomized Treatment | Physician Decision | 1 | 0 |
| Randomized Treatment | Protocol Violation | 1 | 0 |
| Randomized Treatment | Study Closure | 1 | 0 |
| Randomized Treatment | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Active Comparator | Experimental | Total |
|---|---|---|---|
| Age Continuous Age at screening | 67.8 Years STANDARD_DEVIATION 6.01 | 66.2 Years STANDARD_DEVIATION 8.24 | 67.0 Years STANDARD_DEVIATION 7.19 |
| Race/Ethnicity, Customized Black | 1.0 Participants | 0 Participants | 1.0 Participants |
| Race/Ethnicity, Customized Caucasian | 16.0 Participants | 12.0 Participants | 28.0 Participants |
| Race/Ethnicity, Customized Oriental | 0 Participants | 4.0 Participants | 4.0 Participants |
| Race/Ethnicity, Customized Other | 0.0 Participants | 2.0 Participants | 2.0 Participants |
| Sex: Female, Male Female | 8.0 Participants | 6.0 Participants | 14.0 Participants |
| Sex: Female, Male Male | 9.0 Participants | 12.0 Participants | 21.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / — | 26 / — |
| serious Total, serious adverse events | 4 / — | 4 / — |
Outcome results
Primary
Progression Free Survival (PFS)
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
Time frame: Date of randomization to earliest date of objective disease progression
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator | Progression Free Survival (PFS) | 131.0 Days | 95% Confidence Interval 66 |
| Experimental | Progression Free Survival (PFS) | 42.0 Days | 95% Confidence Interval 35 |