Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
Interventions
DRUGErlotinib 150 mg
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 participants, \>/= 18 years of age * Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate hematologic, renal and liver function * Participant initiating treatment with Tarceva according to the Summary of Product Characteristics
Exclusion criteria
* Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label * Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin * Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Approximately 3 years | PFS was defined as the time from initial dose of erlotinib to progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Response | Approximately 3 years | Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions. |
| Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | Baseline up to 3 years | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib 150 mg Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Erlotinib 150 mg |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 70 |
| serious Total, serious adverse events | 19 / 70 |
Outcome results
Primary
Progression-Free Survival (PFS)
PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
Time frame: Approximately 3 years
Population: The effectiveness analysis population included all enrolled participants in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib 150 mg | Progression-Free Survival (PFS) | 2.7 months |
Secondary
Percentage of Participants With Overall Response
Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.
Time frame: Approximately 3 years
Population: The effectiveness analysis population included all enrolled participants in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib 150 mg | Percentage of Participants With Overall Response | 8.57 Percentage of participants |
Secondary
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.
Time frame: Baseline up to 3 years
Population: The safety analysis population included all enrolled participants who received a single dose of erlotinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib 150 mg | Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | AEs | 0.56 Proportion of participants |
| Erlotinib 150 mg | Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | SAEs | 0.27 Proportion of participants |
| Erlotinib 150 mg | Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | AESIs | 0 Proportion of participants |