Lung Cancer
Conditions
Brief summary
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
Detailed description
Upon determination of eligibility, patients will be receive: * Pemetrexed + Gemcitabine
Interventions
DRUGPemetrexed
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
DRUGGemcitabine
1500mg/m2, 30min IV
Sponsors
Eli Lilly and Company
SCRI Development Innovations, LLC
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
To be included in this study, you must meet the following criteria: * Histologically confirmed non-small cell bronchogenic carcinoma * Newly diagnosed or recurrent unresectable stage III or stage IV disease * No mixed tumors with small cell anaplastic elements * Measurable disease * Must not have received any prior antineoplastic chemotherapy for lung cancer * Age \> 18 years * Able to perform activities of daily living with little or no assistance * Adequate bone marrow, liver and kidney * Understand the nature of this study and give written informed consent.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Female patients who are pregnant or are lactating * History of serious cardiovascular disease within the previous six months * Serious active infection at the time of treatment * Other serious underlying medical condition Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 18 months | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 18 months | PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. |
| Overall Survival (OS) | 18 months | OS was measured from the date of study entry until the date of death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 72 / 72 |
| serious Total, serious adverse events | 39 / 72 |
Outcome results
Primary
Overall Response Rate
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Time frame: 18 months
Population: All patients were assessed for response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Overall Response Rate | 26 Percentage of participants |
Secondary
Overall Survival (OS)
OS was measured from the date of study entry until the date of death.
Time frame: 18 months
Population: All patients were assessed for OS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Overall Survival (OS) | 8.5 Months |
Secondary
Progression-free Survival (PFS)
PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Time frame: 18 months
Population: All patients were assessed for PFS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Progression-free Survival (PFS) | 6.2 Months |