Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H3E-XM-S092 |
Not provided
Not provided
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Trial was stopped early due to low enrollment.
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To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m2, intravenous (IV), every 21 days x 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 21 day cycle (3 cycles) and 3-4 weeks after last cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | A Coruña | 15006 |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | every 21 day cycle (3 cycles) and 3-4 weeks after last cycle |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
Trial was stopped early due to low enrollment and the relapse-free survival outcome measure was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cisplatin | Drug | 75 mg/m2, intravenous (IV), every 21 days x 3 cycles |
|
| Relapse-free Survival | Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment. | 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 |
| Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barakaldo | 48903 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | 08035 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | 28034 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pamplona | 31008 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | 46014 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group Functional Status | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Body Mass Index | weight divided by square height | Mean | Standard Deviation | kilograms per square meters |
|
| Corporal Surface (Body Surface Area) | The total surface area of the body (BSA). BSA was calculated by taking the square root of product of the weight in kilograms times the height in centimeters divided by 3600. | Mean | Standard Deviation | square meters |
|
| Height | Mean | Standard Deviation | meters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| 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. | 7 out of the 10 patients had surgery. | Posted | Number | participants | surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) |
|
|
|
| Secondary | Relapse-free Survival | Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment. | Posted | Mean | Standard Deviation | months | 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 |
|
|
| 1 |
| 8 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |