Non-Small Cell Lung Cancer
Conditions
Brief summary
This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.
Interventions
DRUGerlotinib [Tarceva]
150 mg/day until progressive disease or unacceptable toxicity
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * locally advanced or metastatic NSCLC (Stage IIIB or IV); * not a candidate for curative surgery or radical chemotherapy; * no brain metastases, or clinically stable metastases for \>=2 months.
Exclusion criteria
* radiotherapy over the previous 2 weeks; * weight loss \>10% in the previous 6 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression or Death by Line of Treatment | Baseline, every 6-8 weeks up to 3 years until disease progression or death | Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Baseline, every 6-8 weeks up to 3 years or until death | Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response \[CR\], partial response \[PR\], or stable disease \[SD\]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions. |
| Overall Survival (OS) by Line of Treatment | Baseline, every 6-8 weeks up to 3 years, or until death | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date was unavailable\] minus the date of first dose of study medication plus 1 divided by 30.44). |
Countries
Spain
Participant flow
Pre-assignment details
Three cohorts were established in participants with advanced non-small cell lung cancer (NSCLC) based on previous chemotherapy treatment received: first line of treatment (where conventional chemotherapy is not indicated), second line of treatment, and third and subsequent lines of treatment. Inclusion was competitive.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib 150 mg/Day Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity. | 1,805 |
| Total | 1,805 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 117 |
| Overall Study | Clinical Deterioration | 28 |
| Overall Study | Death | 264 |
| Overall Study | Lack of Efficacy | 1,245 |
| Overall Study | Lost to Follow-up | 34 |
| Overall Study | Other | 20 |
| Overall Study | Physician Decision | 17 |
| Overall Study | Protocol Violation | 9 |
| Overall Study | Withdrawal by Subject | 71 |
Baseline characteristics
| Characteristic | Erlotinib 150 mg/Day |
|---|---|
| Age, Continuous | 63.55 years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 520 Participants |
| Sex: Female, Male Male | 1285 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,695 / 1,797 |
| serious Total, serious adverse events | 566 / 1,805 |
Outcome results
Primary
Time to Disease Progression or Death by Line of Treatment
Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.
Time frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death
Population: ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | 1st Line | 3.4 months |
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | Maintenance after 1st Line | 4.7 months |
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | 2nd Line | 2.7 months |
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | Maintenance after 2nd Line | 3.9 months |
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | 3rd or Subsequent Line | 2.4 months |
| Erlotinib 150 mg/Day | Time to Disease Progression or Death by Line of Treatment | Maintenance after 3rd Line | 2.8 months |
Secondary
Overall Survival (OS) by Line of Treatment
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date was unavailable\] minus the date of first dose of study medication plus 1 divided by 30.44).
Time frame: Baseline, every 6-8 weeks up to 3 years, or until death
Population: ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | 1st Line | 6.4 months |
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | Sequential treatment after 1st line | 12.1 months |
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | 2nd Line | 5.9 months |
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | Sequential treatment after 2nd line | 7.1 months |
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | 3rd Line or subsequent | 5.2 months |
| Erlotinib 150 mg/Day | Overall Survival (OS) by Line of Treatment | Sequential treatment after 3rd line | 3.9 months |
Secondary
Percentage of Participants Achieving Clinical Benefit by Line of Treatment
Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response \[CR\], partial response \[PR\], or stable disease \[SD\]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.
Time frame: Baseline, every 6-8 weeks up to 3 years or until death
Population: Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | 1st line | 70.32 percentage of participants |
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Maintenance treatment after 1st line | 70.00 percentage of participants |
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | 2nd line | 58.04 percentage of participants |
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Maintenance treatment after 2nd line | 73.68 percentage of participants |
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | 3rd or subsequent line | 52.71 percentage of participants |
| Erlotinib 150 mg/Day | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Maintenance treatment after 3rd line | 50.00 percentage of participants |