Trial Outcomes & Findings for A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients (NCT NCT01020786)
NCT ID: NCT01020786
Last Updated: 2013-08-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
Results posted on
2013-08-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Induction Period
STARTED
|
109
|
|
Induction Period
COMPLETED
|
60
|
|
Induction Period
NOT COMPLETED
|
49
|
|
Maintenance Period
STARTED
|
60
|
|
Maintenance Period
COMPLETED
|
0
|
|
Maintenance Period
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Induction Period
Entry Criteria Not Met
|
2
|
|
Induction Period
Adverse Event
|
10
|
|
Induction Period
Progressive Disease
|
31
|
|
Induction Period
Investigator Decision
|
3
|
|
Induction Period
Withdrawal by Subject
|
3
|
|
Maintenance Period
Adverse Event
|
8
|
|
Maintenance Period
Progressive Disease
|
43
|
|
Maintenance Period
Withdrawal by Subject
|
8
|
|
Maintenance Period
Sponsor Decision
|
1
|
Baseline Characteristics
A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients
Baseline characteristics by cohort
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Age Continuous
|
63.35 years
STANDARD_DEVIATION 8.692 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
109 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
109 participants
n=5 Participants
|
|
Percentage of Participants in Each Smoking Status Category at Study Entry
Current Smoker
|
8.3 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Smoking Status Category at Study Entry
Former Smoker
|
61.5 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Smoking Status Category at Study Entry
Never Smoker
|
30.3 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Smoking Status Category at Study Entry
Unknown
|
0.0 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Histology Category
Adenocarcinoma Lung
|
97.2 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Histology Category
Large Cell Lung Carcinoma
|
2.8 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Histology Category
Carcinoma, Non-small Cell, Lung Not Otherwise S
|
0 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Disease Stage
Stage IIIb
|
30.3 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Disease Stage
Stage IV
|
66.1 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Disease Stage
Other
|
3.7 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category
Positive
|
22.0 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category
Negative
|
57.8 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category
Unknown
|
2.8 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category
Not Done
|
17.4 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status
0 - Fully Active
|
33.9 percentage of participants
n=5 Participants
|
|
Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status
1 - Ambulatory, Restricted Strenuous Activity
|
66.1 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)Population: 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.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
|
5.6 months
Interval 4.3 to 7.2
|
SECONDARY outcome
Timeframe: Enrollment to the date of death from any cause (up to 30.8 months)Population: 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.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Overall Survival (OS) During the Induction and Maintenance Therapy Periods
Overall Survival (OS) at primary endpoint
|
NA months
The median and 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of the data cutoff.
|
|
Overall Survival (OS) During the Induction and Maintenance Therapy Periods
Overall Survival (OS) at final endpoint
|
20.2 months
Interval 16.7 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the time of final data cutoff.
|
SECONDARY outcome
Timeframe: Enrollment to date of progressive disease (up to 18 months)Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods
CR+PR
|
34.9 percentage of participants
Interval 26.0 to 44.6
|
|
Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods
CR+PR+SD
|
72.5 percentage of participants
Interval 63.1 to 80.6
|
SECONDARY outcome
Timeframe: Enrollment to date of progressive disease (up to 18 months)Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods
CR
|
0.0 percentage of participants
|
|
Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods
PR
|
34.9 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=60 Participants
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.
|
|---|---|
|
Progression Free Survival (PFS) During the Maintenance Therapy Period
PFS at primary endpoint
|
3.9 months
Interval 2.8 to 5.0
|
|
Progression Free Survival (PFS) During the Maintenance Therapy Period
PFS at final endpoint
|
3.9 months
Interval 3.2 to 5.2
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=60 Participants
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.
|
|---|---|
|
Overall Survival (OS) During the Maintenance Therapy Period
Overall Survival (OS) at primary endpoint
|
NA months
The median and the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of the 2-year data cutoff.
|
|
Overall Survival (OS) During the Maintenance Therapy Period
Overall Survival (OS) at final endpoint
|
NA months
Interval 21.0 to
The median and the upper 95% confidence interval were not calculable because an insufficient number of participants reached the event at the time of final data cutoff.
|
SECONDARY outcome
Timeframe: 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)Population: Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=60 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period
CR+PR
|
3.3 percentage of participants
Interval 0.4 to 11.5
|
|
Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period
CR+PR+SD
|
48.3 percentage of participants
Interval 35.2 to 61.6
|
SECONDARY outcome
Timeframe: Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period
|
81.7 percentage of participants
Interval 73.1 to 88.4
|
SECONDARY outcome
Timeframe: Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)Population: Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.
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.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=109 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period
|
38.5 percentage of participants
Interval 29.4 to 48.3
|
Adverse Events
Pemetrexed + Carboplatin
Serious events: 17 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Carboplatin
n=109 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
3/109 • Number of events 3 • 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.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.92%
1/109 • Number of events 1 • 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.
|
|
General disorders
Obstruction
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchitis
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Infections and infestations
Bronchopneumonia
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Infections and infestations
Cellulitis
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Infections and infestations
Tonsillitis
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Investigations
Blood potassium decreased
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Psychiatric disorders
Depression
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.92%
1/109 • Number of events 1 • 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.
|
|
Vascular disorders
Iliac artery occlusion
|
0.92%
1/109 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Pemetrexed + Carboplatin
n=109 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.1%
47/109 • Number of events 59 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
40.4%
44/109 • Number of events 147 • 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.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.8%
14/109 • Number of events 23 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.2%
58/109 • Number of events 193 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.5%
30/109 • Number of events 84 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
9/109 • Number of events 15 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
7/109 • Number of events 7 • 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.
|
|
Gastrointestinal disorders
Cheilitis
|
5.5%
6/109 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Constipation
|
47.7%
52/109 • Number of events 110 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.9%
25/109 • Number of events 37 • 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.
|
|
Gastrointestinal disorders
Nausea
|
74.3%
81/109 • Number of events 206 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
20.2%
22/109 • Number of events 27 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
42.2%
46/109 • Number of events 71 • 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.
|
|
General disorders
Fatigue
|
68.8%
75/109 • Number of events 181 • 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.
|
|
General disorders
Influenza like illness
|
6.4%
7/109 • Number of events 8 • 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.
|
|
General disorders
Injection site reaction
|
9.2%
10/109 • Number of events 10 • 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.
|
|
General disorders
Malaise
|
11.0%
12/109 • Number of events 19 • 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.
|
|
General disorders
Oedema
|
7.3%
8/109 • Number of events 8 • 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.
|
|
General disorders
Pyrexia
|
32.1%
35/109 • Number of events 56 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
7/109 • Number of events 10 • 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.
|
|
Infections and infestations
Pneumonia
|
9.2%
10/109 • Number of events 12 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
56.9%
62/109 • Number of events 152 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
55.0%
60/109 • Number of events 153 • 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.
|
|
Investigations
Blood albumin decreased
|
13.8%
15/109 • Number of events 19 • 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.
|
|
Investigations
Blood alkaline phosphatase increased
|
18.3%
20/109 • Number of events 23 • 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.
|
|
Investigations
Blood bilirubin increased
|
6.4%
7/109 • Number of events 12 • 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.
|
|
Investigations
Blood calcium decreased
|
10.1%
11/109 • Number of events 17 • 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.
|
|
Investigations
Blood creatinine increased
|
8.3%
9/109 • Number of events 17 • 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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
34.9%
38/109 • Number of events 72 • 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.
|
|
Investigations
Blood potassium increased
|
6.4%
7/109 • Number of events 11 • 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.
|
|
Investigations
Blood sodium decreased
|
6.4%
7/109 • Number of events 15 • 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.
|
|
Investigations
Blood urea increased
|
9.2%
10/109 • Number of events 16 • 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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
28.4%
31/109 • Number of events 42 • 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.
|
|
Investigations
Haemoglobin decreased
|
47.7%
52/109 • Number of events 79 • 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.
|
|
Investigations
Neutrophil count decreased
|
27.5%
30/109 • Number of events 98 • 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.
|
|
Investigations
Platelet count decreased
|
59.6%
65/109 • Number of events 225 • 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.
|
|
Investigations
Red blood cell count decreased
|
7.3%
8/109 • Number of events 8 • 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.
|
|
Investigations
Weight decreased
|
10.1%
11/109 • Number of events 15 • 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.
|
|
Investigations
White blood cell count decreased
|
38.5%
42/109 • Number of events 131 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.2%
82/109 • Number of events 199 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.3%
8/109 • Number of events 15 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.5%
6/109 • Number of events 6 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
14/109 • Number of events 14 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
6/109 • Number of events 7 • 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.
|
|
Nervous system disorders
Dizziness
|
18.3%
20/109 • Number of events 27 • 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.
|
|
Nervous system disorders
Dysgeusia
|
10.1%
11/109 • Number of events 13 • 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.
|
|
Nervous system disorders
Headache
|
13.8%
15/109 • Number of events 20 • 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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
9/109 • Number of events 12 • 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.
|
|
Psychiatric disorders
Insomnia
|
21.1%
23/109 • Number of events 28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
16/109 • Number of events 18 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.0%
12/109 • Number of events 14 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
9/109 • Number of events 10 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.3%
8/109 • Number of events 12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
15.6%
17/109 • Number of events 34 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
8/109 • Number of events 8 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
10/109 • Number of events 12 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.9%
37/109 • Number of events 50 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.3%
8/109 • Number of events 8 • 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.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60