Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer Stage IIIB, Nonsquamous Non-Small Cell Neoplasm of Lung
Conditions
Brief summary
The main purpose for this study is to answer the following research questions: * Can pemetrexed be administered safely at the participant's home, using the same treatment procedure as in a hospital setting? * Will the participant be satisfied with home care? * How might this impact the participant's quality of life? * What are the required medical resources needed to give pemetrexed in a home setting?
Interventions
DRUGPemetrexed
Administered intravenously
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a histological or cytological diagnosis of NSCLC defined as nonsquamous cell histology. Squamous cell and/or small cell histology is not permitted. Mixed NSCLC tumors will be categorized by the predominant cell type. NSCLC tumors that are not otherwise specified with regard to histology or cannot be subclassified as squamous, adenocarcinoma, or large cell histology will be categorized as nonsquamous * Have Stage IIIB (not amenable to curative treatment) or Stage IV NSCLC prior to induction therapy as defined by the American Joint Committee on Cancer (AJCC) Staging Criteria for Lung Cancer * Have completed 4 induction cycles of platinum-based doublet therapy (type at the discretion of the physician) for treatment of their advanced disease. * Have not progressed after 4 cycles of induction therapy. Documented radiographic evidence of a tumor response must occur at the end of Cycle 4 of induction therapy within 3 weeks before receiving the first cycle of study drug \[see Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1\] * Receive on-study treatment no earlier than 21 days and no later than 42 days from Cycle 4 Day 1 of induction therapy * Have a Performance Status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Meet the following guidelines if the participant has received prior radiation therapy: * Previous radiation therapy is allowed to \<25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation * Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia) * Participants who received palliative chest (in other words, thoracic skeleton including dorsal spine) or palliative extrathoracic radiotherapy to preexisting lesions are allowed to be enrolled in this trial * Have adequate organ function, including: * Adequate bone marrow reserve: absolute neutrophil count (ANC) (segmented and bands) \>=1.5x109/Liter (L), platelets \>=100x109/L, and hemoglobin \>=9 grams per deciliter (g/dL) * Hepatic: bilirubin \<=1.5 x upper limit of normal (ULN) and alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \<=3.0 x ULN (ALP, AST, and ALT \<=5.0 x ULN are acceptable if the liver has tumor involvement * Renal: calculated creatinine clearance (CrCl) \>=45 milliliters per minute (mL/min) based on the original weight-based Cockcroft and Gault formula * Are willing to comply with the following contraceptive criteria: * Females must be surgically sterile, postmenopausal or must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug * Males and females with reproductive potential: Must agree to use a reliable method of birth control during the study and for 6 months following the last dose of study drug * Have an estimated life expectancy of at least 12 weeks * Have given written informed consent/assent prior to any study-specific procedures * Are willing to comply with home delivery administration and have family or close environment support willing to comply with home delivery administration
Exclusion criteria
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or no approved use of a drug or device (other than pemetrexed used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * Have previously completed or withdrawn from this study * Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) * Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV * Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants for at least 1 week before starting study treatment and their disease is asymptomatic and radiographically stable * Are receiving concurrent administration of any other antitumor therapy * Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results * Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than aspirin dose ≤1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) * Are unable or unwilling to take folic acid or vitamin B12 supplementation * Are unable or unwilling to take corticosteroids * Are pregnant or lactating * Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle) | Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS) | Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation | The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported. |
| Change From Baseline in the EQ-5D Index Score | Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation | The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state. |
| Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation | LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life). |
| Participant Satisfaction: Chemotherapy at Hospital | The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation | Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied. |
| Participant Satisfaction: Chemotherapy at Home | The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation | Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients' support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied. |
| Participant Satisfaction: Regarding the Study Nurse | The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation | Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied. |
| Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation | Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure. |
| Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources | Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle) | The number of participants who had at least 1 unplanned use of health care resources \[accident and emergency department (dept.), specialists \[oncologist, pulmonologist, etcetera (etc.)\], general practitioner (GP) or family doctor, or diagnostic procedures\] during the study is reported. |
| Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle) | The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times. |
| Resource Utilization: Duration of Health Care Visits | Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle) | The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4. |
| Resource Utilization: Distances Traveled | Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle) | The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4. |
| Overall Survival (OS) at 6 Months | Cycle 1, Day 1 to the date of death from any cause (up to Month 6) | The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive). |
| Time to Treatment Failure (TTF) | Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle) | The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed. |
| Physician Satisfaction: Distant Management of Participant | 30 days post treatment discontinuation | The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation] | The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. |
Countries
Sweden, United Kingdom
Participant flow
Pre-assignment details
Participants who completed study treatment and follow-up (FU) were considered to have completed the study. Participants received treatment until disease progression or discontinuation and were followed post treatment (post tx) discontinuation for up to 6 months.
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed Pemetrexed: 500 mg/m\^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to FU post tx discontinuation | 1 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age, Continuous | 66.0 years FULL_RANGE 12.05 |
| Basis for Most Recent Pathological Diagnosis Cytological | 10 participants |
| Basis for Most Recent Pathological Diagnosis Histopathological | 42 participants |
| Best Response to Prior Systemic Therapy Partial Response (PR) | 25 participants |
| Best Response to Prior Systemic Therapy Progressive Disease (PD) | 1 participants |
| Best Response to Prior Systemic Therapy Stable Disease (SD) | 26 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0: Fully Active | 14 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1: Restricted | 38 participants |
| Most Recent Pathological Diagnosis Adenocarcinoma, Lung | 48 participants |
| Most Recent Pathological Diagnosis Adenocarcinoma, Moderately Differentiated, Lung | 1 participants |
| Most Recent Pathological Diagnosis Adenocarcinoma, Mucinous, No Other Symptoms (NOS) | 1 participants |
| Most Recent Pathological Diagnosis Carcinoma, Non-Small Cell, Lung NOS | 2 participants |
| Prior Systemic Therapy Carboplatin + Gemcitabine | 9 participants |
| Prior Systemic Therapy Carboplatin + Pemetrexed | 19 participants |
| Prior Systemic Therapy Cisplatin + Pemetrexed | 20 participants |
| Prior Systemic Therapy Platinum-Based Therapy + Pemetrexed | 4 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants |
| Race/Ethnicity, Customized White | 48 participants |
| Region of Enrollment Sweden | 9 participants |
| Region of Enrollment United Kingdom | 43 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 26 Participants |
| Stage of Disease Stage IIIA | 1 participants |
| Stage of Disease Stage IIIB | 3 participants |
| Stage of Disease Stage IV | 48 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 52 |
| serious Total, serious adverse events | 23 / 52 |
Outcome results
Primary
Percentage of Participants Who Adhered to Treatment Administration at Home
Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.
Time frame: Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)
Population: Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 14, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 13, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 15, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 16, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 17, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 18, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 19, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 1, Hospital Delivery | 100 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 2, Home Delivery | 98.0 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 3, Home Delivery | 98.0 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 4, Home Delivery | 98.0 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 5, Home Delivery | 98.0 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 6, Home Delivery | 98.0 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 7, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 8, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 9, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 10, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 11, Home Delivery | 90.7 percentage of participants |
| Pemetrexed | Percentage of Participants Who Adhered to Treatment Administration at Home | Cycle 12, Home Delivery | 90.7 percentage of participants |
Secondary
Change From Baseline in the EQ-5D Index Score
The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.
Time frame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Change From Baseline in the EQ-5D Index Score | Cycle 2 (n=38) | 0.03 units on a scale | Standard Deviation 0.22 |
| Pemetrexed | Change From Baseline in the EQ-5D Index Score | Cycle 4 (n=23) | 0.08 units on a scale | Standard Deviation 0.22 |
| Pemetrexed | Change From Baseline in the EQ-5D Index Score | 30 days post treatment discontinuation (n=26) | -0.9 units on a scale | Standard Deviation 0.28 |
Secondary
Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.
Time frame: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS) | Cycle 2 (n=34) | 3.0 units on a scale | Standard Deviation 18.6 |
| Pemetrexed | Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS) | Cycle 4 (n=20) | 7.7 units on a scale | Standard Deviation 21.7 |
| Pemetrexed | Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS) | 30 days post treatment discontinuation (n=22) | -0.9 units on a scale | Standard Deviation 18.9 |
Secondary
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).
Time frame: Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Pain (n=40) | 11.8 mm | Standard Deviation 25.1 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Loss of Appetite (n=43) | 16.3 mm | Standard Deviation 22 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Fatigue (n=43) | 24.5 mm | Standard Deviation 27.2 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Cough (n=41) | 9.2 mm | Standard Deviation 19.7 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Dyspnea (n=41) | 17.2 mm | Standard Deviation 26.7 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Hemoptysis (n=43) | 0.4 mm | Standard Deviation 4.3 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Overall Symptomatic Distress (n=43) | 8.3 mm | Standard Deviation 22.3 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Interference With Activity Level (n=43) | 15.3 mm | Standard Deviation 25.1 |
| Pemetrexed | Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | Overall Quality of Life (n=41) | 12.2 mm | Standard Deviation 23 |
Secondary
Overall Survival (OS) at 6 Months
The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).
Time frame: Cycle 1, Day 1 to the date of death from any cause (up to Month 6)
Population: ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed | Overall Survival (OS) at 6 Months | 73 percentage of participants |
Secondary
Participant Satisfaction: Chemotherapy at Home
Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients' support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied.
Time frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q6, Extra burden for family/friends | 1 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q5, No need to travel | 37 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q5, Not having to wait for treatment | 27 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q5, Personalized service | 28 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q5, More privacy | 20 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q5, Other | 2 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q6, Lack of other patients' support | 5 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q6, Safety concerns | 4 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q6, Need to rely on 1 medical specialist | 7 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q6, Other | 19 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q7, Very dissatisfied | 1 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q7, Somewhat dissatisfied | 0 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q7, Neither satisfied nor dissatisfied | 2 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q7, Somewhat satisfied | 1 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Home | Q7, Very Satisfied | 30 participants |
Secondary
Participant Satisfaction: Chemotherapy at Hospital
Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied.
Time frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q2, Lack of privacy on the ward | 7 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q1, Support from other patients | 8 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q1, Access to other medical specialists | 19 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q1, Access to more technical services | 12 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q1, Safer in case something goes wrong | 19 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q1, Other | 3 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q2, Need to travel | 36 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q2, Having to wait for treatment | 27 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q2, Not having a personalized treatment | 5 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q2, Other | 1 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q3, Very dissatisfied | 0 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q3, Somewhat dissatisfied | 3 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q3, Neither satisfied nor dissatisfied | 3 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q3, Somewhat satisfied | 11 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q3, Very satisfied | 21 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q4, Very dissatisfied | 3 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q4, Somewhat dissatisfied | 0 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q4, Neither satisfied nor dissatisfied | 0 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q4, Somewhat satisfied | 3 participants |
| Pemetrexed | Participant Satisfaction: Chemotherapy at Hospital | Q4, Very satisfied | 32 participants |
Secondary
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure.
Time frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q15, Home | 33 participants |
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q15, Hospital | 0 participants |
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q15, Indifferent | 5 participants |
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q16, Yes | 37 participants |
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q16, No | 0 participants |
| Pemetrexed | Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | Q16, Not sure | 0 participants |
Secondary
Participant Satisfaction: Regarding the Study Nurse
Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied.
Time frame: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q8, Yes | 37 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q8, No | 0 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q9, Yes | 36 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q9, No | 1 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q10, Yes | 37 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q10, No | 1 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q11, Yes | 36 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q11, No | 0 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q12, Yes | 34 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q12, No | 0 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q12, Uncertain | 3 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q13, Hardly any reassurance and support | 0 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q13, Some reassurance and support | 2 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q13, A lot of reassurance and support | 35 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q14, Very dissatisfied | 3 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q14, Somewhat dissatisfied | 0 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q14, Neither satisfied nor dissatisfied | 1 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q14, Somewhat satisfied | 1 participants |
| Pemetrexed | Participant Satisfaction: Regarding the Study Nurse | Q14, Very satisfied | 33 participants |
Secondary
Physician Satisfaction: Distant Management of Participant
The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied.
Time frame: 30 days post treatment discontinuation
Population: Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Physician Satisfaction: Distant Management of Participant | Very Dissatisfied | 2 investigators |
| Pemetrexed | Physician Satisfaction: Distant Management of Participant | Somewhat Dissatisfied | 1 investigators |
| Pemetrexed | Physician Satisfaction: Distant Management of Participant | Neither Satisfied Nor Dissatisfied | 0 investigators |
| Pemetrexed | Physician Satisfaction: Distant Management of Participant | Somewhat Satisfied | 8 investigators |
| Pemetrexed | Physician Satisfaction: Distant Management of Participant | Very Satisfied | 20 investigators |
Secondary
Resource Utilization: Distances Traveled
The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.
Time frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)
Population: Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 1, Home to Hospital, Great Britain (n=25) | 19.7 kilometers (km) | Standard Deviation 23.39 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 1, Home to Hospital, Sweden (n=7) | 30.7 kilometers (km) | Standard Deviation 23.08 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 2, Hospital to Home, Great Britain (n=24) | 15.5 kilometers (km) | Standard Deviation 13.12 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 2, Hospital to Home, Sweden (n=7) | 23.9 kilometers (km) | Standard Deviation 23.93 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 3, Hospital to Home, Great Britain (n=11) | 23.8 kilometers (km) | Standard Deviation 16.72 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 3, Hospital to Home, Sweden (n=4) | 17.5 kilometers (km) | Standard Deviation 17.97 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 4, Hospital to Home, Great Britain (n=7) | 11.7 kilometers (km) | Standard Deviation 8.75 |
| Pemetrexed | Resource Utilization: Distances Traveled | Cycle 4, Hospital to Home, Sweden (n=2) | 24.5 kilometers (km) | Standard Deviation 27.58 |
Secondary
Resource Utilization: Duration of Health Care Visits
The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.
Time frame: Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)
Population: Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Resource Utilization: Duration of Health Care Visits | Cycle 4 (n=28) | 1.57 hours | Standard Deviation 0.311 |
| Pemetrexed | Resource Utilization: Duration of Health Care Visits | Cycle 2 (n=42) | 1.67 hours | Standard Deviation 0.493 |
| Pemetrexed | Resource Utilization: Duration of Health Care Visits | Cycle 3 (n=35) | 1.66 hours | Standard Deviation 0.683 |
Secondary
Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources
The number of participants who had at least 1 unplanned use of health care resources \[accident and emergency department (dept.), specialists \[oncologist, pulmonologist, etcetera (etc.)\], general practitioner (GP) or family doctor, or diagnostic procedures\] during the study is reported.
Time frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
Population: ITT population: Participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed | Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources | 29 participants |
Secondary
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.
Time frame: Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
Population: Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 1 Unplanned Visit, Any Resource | 8 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 2 Unplanned Visits, Any Resource | 6 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 3 Unplanned Visits, Any Resource | 5 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 4 Unplanned Visits, Any Resource | 2 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 5 Unplanned Visits, Any Resource | 3 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 9 Unplanned Visits, Any Resource | 1 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 10 Unplanned Visits, Any Resource | 1 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 13 Unplanned Visits, Any Resource | 1 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 1 Unplanned Visit, Accident and Emergency Dept. | 7 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 2 Unplanned Visits, Accident and Emergency Dept. | 2 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 3 Unplanned Visits, Accident and Emergency Dept. | 2 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 1 Unplanned Visit, Specialist | 9 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 2 Unplanned Visits, Specialist | 3 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 5 Unplanned Visits, Specialist | 1 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 1 Unplanned Visit, GP or Family Doctor | 6 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 2 Unplanned Visits, GP or Family Doctor | 3 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 3 Unplanned Visits, GP or Family Doctor | 2 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 4 Unplanned Visits, GP or Family Doctor | 3 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 1 Unplanned Visit, Diagnostic procedures | 6 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 2 Unplanned Visits, Diagnostic procedures | 2 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 3 Unplanned Visits, Diagnostic procedures | 3 participants |
| Pemetrexed | Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | 4 Unplanned Visits, Diagnostic procedures | 1 participants |
Secondary
Time to Treatment Failure (TTF)
The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.
Time frame: Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)
Population: ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Time to Treatment Failure (TTF) | 3.0 months |
Other Pre-specified
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Time frame: First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
Population: Safety Population: Participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | At least 1 TEAE | 51 participants |
| Pemetrexed | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | At least 1 Serious TEAE | 21 participants |
| Pemetrexed | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | Death, AE (fell, multiple injuries) | 1 participants |
| Pemetrexed | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | Death, Study Drug Toxicity (atypical pneumonia) | 1 participants |
| Pemetrexed | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | Death, Study Disease | 26 participants |