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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-JE-JMII | Other Identifier | Eli Lilly and Company |
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To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed + Carboplatin | Experimental | After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | Induction Therapy: 500 milligrams per square meter (mg/m^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods | PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. | Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) During the Induction and Maintenance Therapy Periods | OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact. | Enrollment to the date of death from any cause (up to 30.8 months) |
| Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods |
Not provided
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 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. | Aichi | 460-0001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23475281 | Derived | Okamoto I, Aoe K, Kato T, Hosomi Y, Yokoyama A, Imamura F, Kiura K, Hirashima T, Nishio M, Nogami N, Okamoto H, Saka H, Yamamoto N, Yoshizuka N, Sekiguchi R, Kiyosawa K, Nakagawa K, Tamura T. Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naive patients with advanced nonsquamous non-small-cell lung cancer. Invest New Drugs. 2013 Oct;31(5):1275-82. doi: 10.1007/s10637-013-9941-z. Epub 2013 Mar 10. |
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Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after).
Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Carboplatin | Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Period |
|
| ||||||||||||||||||||||||
| Maintenance Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Carboplatin | Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. |
| 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 | Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods | PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. | Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD. | Posted | Median | 95% Confidence Interval | months | Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months) |
|
Treatment period plus 30 day follow-up period (up to 30.8 months)
Adverse events were updated to add the adverse events occurring after the data cut-off date for the primary endpoint (PFS) to those events previously reported.
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 + Carboplatin | Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 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 |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
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Not provided
|
| Carboplatin | Drug | Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles. |
|
Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria. |
| Enrollment to date of progressive disease (up to 18 months) |
| Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods | Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria. | Enrollment to date of progressive disease (up to 18 months) |
| Progression Free Survival (PFS) During the Maintenance Therapy Period | Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months) |
| Overall Survival (OS) During the Maintenance Therapy Period | OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact. | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months) |
| Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period | Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) |
| Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period | Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria. | Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle) |
| Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period | Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria. | Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle) |
| Japan |
| 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. | Chiba | 277 8577 | Japan |
| 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. | Ehime | 790-0007 | Japan |
| 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. | Fukuoka | 812-8582 | Japan |
| 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. | Hokkaido | 062-0931 | Japan |
| 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. | Hyōgo | 673-8558 | Japan |
| 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. | Kanagawa | 236-0051 | Japan |
| 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. | Kumamoto | 860-8556 | Japan |
| 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. | Miyagi | 980-8574 | Japan |
| 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. | Niigata | 951-8520 | Japan |
| 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. | Okayama | 700-8558 | Japan |
| 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. | Osaka | 589-8511 | Japan |
| 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. | Shizuoka | 411-8777 | Japan |
| 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. | Tochigi | 320-0834 | Japan |
| 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. | Tokyo | 113-8677 | Japan |
| 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. | Yamaguchi | 755-0241 | Japan |
| Investigator Decision |
|
| Withdrawal by Subject |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage of Participants in Each Smoking Status Category at Study Entry | Percentage of participants in each category for smoking status. All of the percentages do not add up to 100% because of rounding. | Number | percentage of participants |
|
| Percentage of Participants in Each Histology Category | Percentage of participants in each of the following categories: adenocarcinoma, large cell lung carcinoma, and carcinoma, non-small cell, lung not otherwise specified (NOS). | Number | percentage of participants |
|
| Percentage of Participants in Each Disease Stage | Percentage of participants in each disease stage category. Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body. Stage IIIB - cancer spread to opposite side of chest, more than 1 tumor within same lobe of lung; Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. All of the percentages do not add up to 100% because of rounding. | Number | percentage of participants |
|
| Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category | Percentage of participants in each EGFR mutation status category. | Number | percentage of participants |
|
| Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status | ECOG Performance Status (PS). Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active
| Number | percentage of participants |
|
| Description |
|---|
| OG000 | Pemetrexed + Carboplatin | Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles. Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles. Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity. |
|
|
| Secondary | Overall Survival (OS) During the Induction and Maintenance Therapy Periods | OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact. | Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off. | Posted | Median | 95% Confidence Interval | months | Enrollment to the date of death from any cause (up to 30.8 months) |
|
|
|
| Secondary | Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods | Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria. | Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment to date of progressive disease (up to 18 months) |
|
|
|
| Secondary | Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods | Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria. | Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin. | Posted | Number | percentage of participants | Enrollment to date of progressive disease (up to 18 months) |
|
|
|
| Secondary | Progression Free Survival (PFS) During the Maintenance Therapy Period | Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. | Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off. | Posted | Median | 95% Confidence Interval | months | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months) |
|
|
|
| Secondary | Overall Survival (OS) During the Maintenance Therapy Period | OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact. | Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively. | Posted | Median | 95% Confidence Interval | months | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months) |
|
|
|
| Secondary | Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period | Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. | Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed. | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) |
|
|
|
| Secondary | Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period | Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria. | Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle) |
|
|
|
| Secondary | Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period | Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria. | Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle) |
|
|
|
| 17 |
| 109 |
| 109 |
| 109 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Obstruction | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |