Non-Small-Cell Lung Cancer
Conditions
Brief summary
To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
Interventions
DRUGpemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
DRUGcisplatin
75 mg/m2, intravenous (IV), every 21 days x 3 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-small-cell carcinoma of the lung * Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon * Tumour with possibility of curative surgery * At least one uni-dimensionally measurable lesion * Adequate pulmonary function to perform the planned surgical resection
Exclusion criteria
* Active infection (at the investigator's discretion) * Pregnancy or breast-feeding * Serious concomitant illness at the investigator's discretion * Previous diagnosis of malignant disease * They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response | every 21 day cycle (3 cycles) and 3-4 weeks after last cycle | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Remissions After Surgery | surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) | The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination. |
| Relapse-free Survival | Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter | Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pemetrexed + Cisplatin |
|---|---|
| Age Continuous | 61.6 years STANDARD_DEVIATION 8.2 |
| Body Mass Index | 27.1 kilograms per square meters STANDARD_DEVIATION 4.3 |
| Corporal Surface (Body Surface Area) | 1.8 square meters STANDARD_DEVIATION 0.2 |
| Eastern Cooperative Oncology Group Functional Status 0 - Fully Active | 8 participants |
| Eastern Cooperative Oncology Group Functional Status 1 - Ambulatory, Restricted Strenuous Activity | 2 participants |
| Eastern Cooperative Oncology Group Functional Status 2 - Ambulatory, No Work Activities | 0 participants |
| Eastern Cooperative Oncology Group Functional Status 3 - Partially Confined to Bed, Limited Self Care | 0 participants |
| Eastern Cooperative Oncology Group Functional Status 4 - Completely Disabled | 0 participants |
| Height | 1.6 meters STANDARD_DEVIATION 0.1 |
| Race/Ethnicity Caucasian | 10 participants |
| Region of Enrollment Spain | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 72.8 kilograms STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / — |
| serious Total, serious adverse events | 1 / — |
Outcome results
Primary
Treatment Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.
Time frame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed + Cisplatin | Treatment Response | Partial Response | 5 participants |
| Pemetrexed + Cisplatin | Treatment Response | Incomplete Response/Stable Disease | 4 participants |
| Pemetrexed + Cisplatin | Treatment Response | Progressive Disease | 1 participants |
| Pemetrexed + Cisplatin | Treatment Response | Not Evaluable | 0 participants |
| Pemetrexed + Cisplatin | Treatment Response | Complete Response | 0 participants |
Secondary
Pathologic Remissions After Surgery
The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
Time frame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)
Population: 7 out of the 10 patients had surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed + Cisplatin | Pathologic Remissions After Surgery | Complete Remission - Yes | 5 participants |
| Pemetrexed + Cisplatin | Pathologic Remissions After Surgery | Complete Remission - No | 2 participants |
Secondary
Relapse-free Survival
Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.
Time frame: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter