Non-small Cell Lung Cancer
Conditions
Brief summary
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.
Interventions
DRUGBevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
DRUGCisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
DRUGDocetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.
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. * Stage IIIb or IV non-small cell lung cancer. * Chemotherapy-naive.
Exclusion criteria
* Previous treatment for non-small cell lung cancer. * Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study. * Recent or current chronic treatment with aspirin (\> 325 mg/day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Baseline to the end of the study (up to 4 years) | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Response | Baseline to the end of the study (up to 4 years) | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. |
| Duration of the Objective Response | Baseline to the end of the study (up to 4 years) | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. |
| Overall Survival | Baseline to the end of the study (up to 4 years) | Overall survival is defined as the time from the first dose of study medication until death. |
| 1-year Survival | Baseline to 1 year | The probability of surviving 1 year was estimated using the Kaplan-Meier method. |
Countries
Spain
Participant flow
Pre-assignment details
The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab + Cisplatin + Docetaxel Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Disease Progression | 23 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Reason not Specified | 6 |
| Overall Study | Withdrawal of Consent | 1 |
Baseline characteristics
| Characteristic | Bevacizumab + Cisplatin + Docetaxel |
|---|---|
| Age, Continuous | 58.31 Years STANDARD_DEVIATION 9.54 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 49 |
| serious Total, serious adverse events | 26 / 49 |
Outcome results
Primary
Progression-free Survival
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Time frame: Baseline to the end of the study (up to 4 years)
Population: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Cisplatin + Docetaxel | Progression-free Survival | 8.95 Months |
Secondary
1-year Survival
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Time frame: Baseline to 1 year
Population: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Cisplatin + Docetaxel | 1-year Survival | 53.46 Percentage of participants |
Secondary
Duration of the Objective Response
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Time frame: Baseline to the end of the study (up to 4 years)
Secondary
Overall Survival
Overall survival is defined as the time from the first dose of study medication until death.
Time frame: Baseline to the end of the study (up to 4 years)
Population: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Cisplatin + Docetaxel | Overall Survival | 12.74 Months |
Secondary
Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Time frame: Baseline to the end of the study (up to 4 years)
Population: Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Cisplatin + Docetaxel | Percentage of Participants With an Objective Response | 67.39 Percentage of participants |