Non-Small Cell Lung Cancer
Conditions
Keywords
Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774
Brief summary
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
Interventions
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
DRUGCombination carboplatin and paclitaxel
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
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
* Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) * No prior chemotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 2 * Clinically or radiologically measurable disease per RECIST criteria
Exclusion criteria
* Gastro-intestinal abnormalities * Any concurrent anticancer therapy * Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind * Other active malignancies * Uncontrolled brain metastases * Severe abnormalities of the cornea * Significant cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Until time of disease progression (maximum 5 months) | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From first study treatment until time of death (maximum 26.8 months) | Median number of months from first study treatment until time of death |
| Best Tumor Response | While receiving study treatment (maximum 60 weeks) | 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 20% larger than at baseline. |
Countries
United States
Participant flow
Recruitment details
The first patient was treated 17 March 2004 and the last patient completed 19 March 2007.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Erlotinib 150 mg/day continuous therapy | 52 |
| Standard Chemotherapy Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | Erlotinib | Standard Chemotherapy | Total |
|---|---|---|---|
| Age Continuous | 69 years | 67 years | 68 years |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black | 12 participants | 10 participants | 22 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants | 7 participants | 11 participants |
| Race/Ethnicity, Customized White | 35 participants | 33 participants | 68 participants |
| Sex: Female, Male Female | 29 Participants | 23 Participants | 52 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / 52 | 50 / 51 |
| serious Total, serious adverse events | 24 / 52 | 13 / 51 |
Outcome results
Primary
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 (maximum 5 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 | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Progression-free Survival | 1.91 months |
| Standard Chemotherapy | Progression-free Survival | 3.52 months |
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 20% larger than at baseline.
Time frame: While receiving study treatment (maximum 60 weeks)
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 | Partial Response (PR) | 2 participants |
| Erlotinib | Best Tumor Response | Progressive Disease (PD) | 23 participants |
| Erlotinib | Best Tumor Response | Stable Disease (SD) | 19 participants |
| Erlotinib | Best Tumor Response | Unable to Determine/Not Evaluable | 8 participants |
| Erlotinib | Best Tumor Response | Complete Response (CR) | 0 participants |
| Standard Chemotherapy | Best Tumor Response | Unable to Determine/Not Evaluable | 12 participants |
| Standard Chemotherapy | Best Tumor Response | Complete Response (CR) | 0 participants |
| Standard Chemotherapy | Best Tumor Response | Partial Response (PR) | 6 participants |
| Standard Chemotherapy | Best Tumor Response | Stable Disease (SD) | 23 participants |
| Standard Chemotherapy | Best Tumor Response | Progressive Disease (PD) | 10 participants |
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 26.8 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 | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival | 6.57 months |
| Standard Chemotherapy | Overall Survival | 9.53 months |