Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Interventions
DRUGErlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥ 18 years of age. * Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors). * Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).
Exclusion criteria
* Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting. * Contraindication for Tarceva according to the Summary of Product characteristics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Baseline to the end of the study (up to 2 years) | Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | Baseline to the end of the study (up to 2 years) | Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. |
| Overall Survival | Up to 2 years | Overall survival was defined as the time from Baseline until death from any cause. |
| Percentage of Participants Who Developed Rash | Up to 2 years | — |
| Percentage of Participants Who Developed Diarrhea | Up to 2 years | — |
Countries
Belgium
Participant flow
Recruitment details
Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 42 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Study termination | 9 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 57 |
| serious Total, serious adverse events | 17 / 57 |
Outcome results
Primary
Progression-free Survival
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Baseline to the end of the study (up to 2 years)
Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Progression-free Survival | 1.8 Months |
Secondary
Best Overall Response
Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time frame: Baseline to the end of the study (up to 2 years)
Population: Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib | Best Overall Response | Complete Response | 0.0 Percentage of participants |
| Erlotinib | Best Overall Response | Partial Response | 0.0 Percentage of participants |
| Erlotinib | Best Overall Response | Stable Disease | 34.6 Percentage of participants |
| Erlotinib | Best Overall Response | Progressive Disease | 65.4 Percentage of participants |
Secondary
Overall Survival
Overall survival was defined as the time from Baseline until death from any cause.
Time frame: Up to 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival | 5.8 months |
Secondary
Percentage of Participants Who Developed Diarrhea
Time frame: Up to 2 years
Population: Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Percentage of Participants Who Developed Diarrhea | 42.8 percentage of participants |
Secondary
Percentage of Participants Who Developed Rash
Time frame: Up to 2 years
Population: Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Percentage of Participants Who Developed Rash | 60.7 percentage of participants |