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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-EZ-S114 | Other Identifier | Eli Lilly and Company |
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This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Pemetrexed + Best Supportive Care | Experimental | Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
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| B: Best Supportive Care | Active Comparator | Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival During Maintenance Phase | Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment. | Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) | Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm 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. | Asyut | 0000 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23006447 | Derived | Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423. |
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Induction phase (IP) is from first dose of study drug until randomization and entering to maintenance phase (MP) or discontinuation from treatment during IP. 106 participants were treated during IP. MP is from randomization to discontinuation from treatment. Overall period is IP+MP, whereas overall study is MP only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed Plus Cisplatin (Induction Phase) | Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles |
| FG001 | Pemetrexed Plus Best Supportive Care (Maintenance Phase) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Phase |
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| Best Supportive Care | Drug | Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
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| First dose of study drug during IP to PD or date of death from any cause up to 33.6 months |
| Overall Survival During Maintenance Phase | Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact. | Randomization to PD or date of death from any cause up to 31.3 months |
| Overall Survival During Overall Period (IP + MP) | Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact. | First dose of study drug during IP to PD or date of death from any cause up to 34.1 months |
| Number of Participants With Adverse Events (AEs) During Overall Period | The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section. | First dose of study drug during IP through overall study completion (up to 34.3) months |
| Tumor Response Rate and Disease Control Rate After Induction Phase (IP) | Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Randomization to measured PD up to 31.4 months |
| Egypt |
| 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. | Cairo | 11372 | Egypt |
| 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. | Mounofia | 32514 | Egypt |
| 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. | Beirut | Lebanon |
| 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. | Riyadh | 11211 | Saudi Arabia |
Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
| FG002 | Best Supportive Care (Maintenance Phase) | Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed Plus Best Supportive Care (Maintenance Phase) | Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
| BG001 | Best Supportive Care (Maintenance Phase) | Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Pathological Diagnosis | Number | participants |
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| Stage of Disease at The Time of Entry into This Study | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status at randomization of maintenance phase | Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Lesion Response to induction phase | The lesions response is classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Complete Response (CR): disappearance of all target lesions; Partial Response: (PR) ≥30% decrease in sum of longest diameter of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: ≥20% increase in sum of longest diameter of target lesions). | Number | participants |
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| 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 | Progression Free Survival During Maintenance Phase | Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment. | Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline. | Posted | Median | 95% Confidence Interval | months | Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months |
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| Secondary | Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) | Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment. | Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline. | Posted | Median | 95% Confidence Interval | months | First dose of study drug during IP to PD or date of death from any cause up to 33.6 months |
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| Secondary | Overall Survival During Maintenance Phase | Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact. | Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline. | Posted | Median | 95% Confidence Interval | months | Randomization to PD or date of death from any cause up to 31.3 months |
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| Secondary | Overall Survival During Overall Period (IP + MP) | Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact. | Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline. | Posted | Median | 95% Confidence Interval | months | First dose of study drug during IP to PD or date of death from any cause up to 34.1 months |
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| Secondary | Number of Participants With Adverse Events (AEs) During Overall Period | The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section. | Participants who took at least one dose of study drug during IP, and randomized to maintenance phase. | Posted | Number | participants | First dose of study drug during IP through overall study completion (up to 34.3) months |
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| Secondary | Tumor Response Rate and Disease Control Rate After Induction Phase (IP) | Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to measured PD up to 31.4 months |
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Adverse events include pre-existing conditions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pemetrexed Plus Best Supportive Care - Maintenance Phase | Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. | 1 | 28 | 15 | 28 | ||
| EG001 | Best Supportive Care - Maintenance Phase | Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. | 1 | 27 | 16 | 27 | ||
| EG002 | Pemetrexed + Cisplatin - Induction Phase | Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles. | 13 | 106 | 74 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Deafness | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Altered state of consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Diabetic ketoacidotic hyperglycaemic coma | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Arterial thrombosis limb | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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Due to a mistake in the randomization parameters form, the randomization was actually implemented in the ratio of 1:1 instead of the planned ratio of 2:1.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | 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 |
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| Lost to Follow-up |
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| Male |
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| African |
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| Saudi Arabia |
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| Lebanon |
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| Large Cells Lung Carcinoma |
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| Adenocarcinoma |
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| Stage IV - Metastasized |
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| 1 - Ambulatory, restricted strenuous activity |
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| 2 - Ambulatory, unable to carry out work activity |
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| Partial Response (PR) |
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| Stable Disease (SD) |
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| Unknown |
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