Pulmonary Cancer
Conditions
Keywords
Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation, Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation, Recurrent pulmonary adenocarcinoma with EGFR mutation
Brief summary
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
Interventions
DRUGGefitinib
250mg tablet oral tablet once daily
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis * WHO Performance Status 0-2 * No prior chemotherapy, biological or immunological therapy/surgery
Exclusion criteria
* Any evidence of clinically active interstitial lung disease * Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation * Patients with previously diagnosed and treated CNS metastases or spinal cord compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. | baseline to 12 months | Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | baseline to 4 months | Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided. |
| Overall Survival (OS) | baseline to 12 months | Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided. |
| Safety Profile: Participants With Adverse Events | baseline to end of study | Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section. |
Countries
South Korea
Participant flow
Recruitment details
147 patients were screened for epidermal growth factor receptor (EGFR) mutation and 46 patients were enrolled in this study. Subjects were recruited by 7 investigational centers throughout South Korea from Mar 2006 to May 2007
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib Gefitinib 250mg tablet | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Not Eligible for the study | 2 |
| Overall Study | Objective Disease Progression | 16 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gefitinib |
|---|---|
| Age Continuous | 60 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / — |
| serious Total, serious adverse events | 4 / — |
Outcome results
Primary
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Time frame: baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. | 0 Percent of Participants |
Secondary
Overall Survival (OS)
Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
Time frame: baseline to 12 months
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Gefitinib | Overall Survival (OS) | 82.26 Percent of Participants | 0 |
Secondary
Progression Free Survival (PFS)
Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Time frame: baseline to 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Progression Free Survival (PFS) | 86.25 Percent of Participants |
Secondary
Safety Profile: Participants With Adverse Events
Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Time frame: baseline to end of study