Non-small Cell Lung Cancer Metastatic
Conditions
Brief summary
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Interventions
DRUGErlotinib
150 mg po daily
DRUGGemcitabine
1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
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; * advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer; * no previous systemic chemotherapy, radiation therapy or immunotherapy; * Eastern Cooperative Oncology Group (ECOG) \>=2.
Exclusion criteria
* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors; * active, non-controlled systemic disease; * any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression | From the time of randomization until disease progression or death (up to 193 weeks)] | Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first. |
| Overall Response Rate (ORR) | From the time of randomization until disease progression or death (up to 193 weeks) | Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From the time of randomization until death (up to 193 weeks) | Overall survival was defined as the interval between the day of randomization and the date of death from any cause. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib + Gemcitabine Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 8 |
Baseline characteristics
| Characteristic | Erlotinib + Gemcitabine |
|---|---|
| Age, Continuous | 62.47 years STANDARD_DEVIATION 9.67 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 19 |
| serious Total, serious adverse events | 2 / 19 |
Outcome results
Primary
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)
Population: ITT population included all participants who were randomized to treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib + Gemcitabine | Overall Response Rate (ORR) | 15.8 percentage of participants |
Primary
Time to Disease Progression
Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)]
Population: Intention to treat (ITT) population included all participants who were randomized to treatment group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib + Gemcitabine | Time to Disease Progression | 15 weeks |
Secondary
Overall Survival
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Time frame: From the time of randomization until death (up to 193 weeks)
Population: ITT population included all participants who were randomized to treatment group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib + Gemcitabine | Overall Survival | 39 weeks |