Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
NSCLC, Erlotinib, Tarceva, Lung Cancer
Brief summary
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
Interventions
Sponsors
OSI Pharmaceuticals
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
* Age \>= 18 * Histologically or cytologically documented non-small cell lung cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2 * Radiologically measurable or evaluable disease No prior chemotherapy * 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening * Tumor tissue block or fine needle aspirate
Exclusion criteria
* Any concurrent anticancer therapy or radiation * Other active malignancy * Uncontrolled brain metastases * GI abnormalities * Severe abnormalities of the cornea * Significant cardiac disease * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month Progression-free Survival | 6 months after first dose | Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Until time of disease progression, as assessed every 21 days (maximum 28.8 months) | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. |
| Overall Survival at 12 Months | 12 months from 1st dose | Percentage of patients alive after 12 months of study treatment |
| Overall Survival | From first study treatment until time of death (maximum 29.0 months) | Median number of months from first study treatment until time of death |
| Best Tumor Response | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months) | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline |
| Duration of Tumor Response | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). | Median length of time that tumor showed any type of response, ie, CR, PR, or SD |
Countries
United Kingdom, United States
Participant flow
Recruitment details
The first patient was treated 28 March 2006 and the analysis database locked 20 March 2009
Pre-assignment details
All enrolled patients were randomly assigned to 1 of 2 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib 150 mg erlotinib daily | 72 |
| Erlotinib + Chemotherapy (Intercalated) carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m\^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity | 71 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive study treatment | 3 | 3 |
Baseline characteristics
| Characteristic | Erlotinib | Erlotinib + Chemotherapy (Intercalated) | Total |
|---|---|---|---|
| Age Continuous | 63 years | 63 years | 63 years |
| Race/Ethnicity, Customized Asian | 9 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 52 Participants | 113 Participants |
| Sex: Female, Male Female | 44 Participants | 31 Participants | 75 Participants |
| Sex: Female, Male Male | 28 Participants | 40 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 69 | 67 / 68 |
| serious Total, serious adverse events | 27 / 69 | 27 / 68 |
Outcome results
Primary
6-month Progression-free Survival
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Time frame: 6 months after first dose
Population: All patients who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | 6-month Progression-free Survival | 30.7 Percentage of Patients |
| Erlotinib + Chemotherapy (Intercalated) | 6-month Progression-free Survival | 26.4 Percentage of Patients |
Secondary
Best Tumor Response
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Population: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib | Best Tumor Response | Complete Response (CR) | 0 Percent of Patients |
| Erlotinib | Best Tumor Response | Progressive Disease (PD) | 46.4 Percent of Patients |
| Erlotinib | Best Tumor Response | Stable Disease (SD) | 34.8 Percent of Patients |
| Erlotinib | Best Tumor Response | Unable to Determine/Not Evaluable | 7.2 Percent of Patients |
| Erlotinib | Best Tumor Response | Partial Response (PR) | 11.6 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Best Tumor Response | Unable to Determine/Not Evaluable | 10.4 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Best Tumor Response | Partial Response (PR) | 22.4 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Best Tumor Response | Complete Response (CR) | 0 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Best Tumor Response | Stable Disease (SD) | 49.3 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Best Tumor Response | Progressive Disease (PD) | 17.9 Percent of Patients |
Secondary
Duration of Tumor Response
Median length of time that tumor showed any type of response, ie, CR, PR, or SD
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Population: All patients who had any type of tumor response, ie, CR, PR, or SD
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Duration of Tumor Response | 6.4 Months |
| Erlotinib + Chemotherapy (Intercalated) | Duration of Tumor Response | 4.1 Months |
Secondary
Overall Survival
Median number of months from first study treatment until time of death
Time frame: From first study treatment until time of death (maximum 29.0 months)
Population: All patients who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival | 16.72 Months |
| Erlotinib + Chemotherapy (Intercalated) | Overall Survival | 11.43 Months |
Secondary
Overall Survival at 12 Months
Percentage of patients alive after 12 months of study treatment
Time frame: 12 months from 1st dose
Population: All patients who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Overall Survival at 12 Months | 58.6 Percent of Patients |
| Erlotinib + Chemotherapy (Intercalated) | Overall Survival at 12 Months | 46.4 Percent of Patients |
Secondary
Progression-free Survival
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Time frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
Population: All patients who received at least 1 dose of study drug
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Progression-free Survival | 2.69 months |
| Erlotinib + Chemotherapy (Intercalated) | Progression-free Survival | 4.57 months |