Non Small Cell Lung Cancer
Conditions
Brief summary
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
Interventions
DRUGpemetrexed
500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles
DRUGcarboplatin
Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV * No previous chemotherapy for lung cancer * Men and women \> or = 70 years * At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors \[RECIST\]criteria) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Exclusion criteria
* Treatment within the last 30 days with a drug that has not received regulatory approval * Serious systemic disorders * Inability to discontinue administration of aspirin or anti-inflammatory non steroid * Concurrent administration of any other antitumor therapy * Brain metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) | baseline to measured objective tumor response (up to six 21-day cycles) | Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | baseline to stopping treatment (up to six 21-day cycles) | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. |
| Overall Survival | baseline to date of death from any cause (up to 14.5 months) | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
| Estimated Probability of One Year Progression-free Survival | baseline to measured progressive disease or death, 1 year | Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | baseline to stopping treatment (up to six 21-day cycles) | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed + Carboplatin Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death from Study Disease | 1 |
| Overall Study | Death from Study Drug Toxicity | 1 |
| Overall Study | Death Not Study Drug Related | 2 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pemetrexed + Carboplatin |
|---|---|
| Age Continuous | 76.5 years STANDARD_DEVIATION 3.6 |
| Disease Stage Stage IIIB | 13 participants |
| Disease Stage Stage IV | 49 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active | 10 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 52 participants |
| Pathological Diagnosis Adenocarcinoma of Lung | 32 participants |
| Pathological Diagnosis Large Cell Lung Cancer | 5 participants |
| Pathological Diagnosis Other: Carcinoma | 1 participants |
| Pathological Diagnosis Other: Carcinoma-Infiltrant Indifferencie | 1 participants |
| Pathological Diagnosis Other: Indifferencied Non-Small Cell Lung Cancer | 1 participants |
| Pathological Diagnosis Other: Undifferentiated | 1 participants |
| Pathological Diagnosis Squamous Cell Carcinoma of Lung | 21 participants |
| Region of Enrollment France | 62 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 61 / 62 |
| serious Total, serious adverse events | 26 / 62 |
Outcome results
Primary
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
Time frame: baseline to measured objective tumor response (up to six 21-day cycles)
Population: Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed + Carboplatin | Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) | 28.6 percentage of participants |
Secondary
Estimated Probability of One Year Progression-free Survival
Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.
Time frame: baseline to measured progressive disease or death, 1 year
Population: Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed + Carboplatin | Estimated Probability of One Year Progression-free Survival | 13.1 percentage of patients |
Secondary
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline to date of death from any cause (up to 14.5 months)
Population: Twenty patients were censored as they were still alive at the time of the data cut-off.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed + Carboplatin | Overall Survival | 10.4 months |
Secondary
Time to Treatment Failure
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time frame: baseline to stopping treatment (up to six 21-day cycles)
Population: All treated patients. 29 patients were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed + Carboplatin | Time to Treatment Failure | 16.0 weeks |
Other Pre-specified
Time to Treatment Failure
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time frame: baseline to stopping treatment (up to six 21-day cycles)
Population: All treated patients. 29 patients were censored.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pemetrexed + Carboplatin | Time to Treatment Failure | 12.95 weeks | Standard Error 0.74 |