A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01473563
• Collaborator: (none)
• Enrollment: 52
• Locations: 9
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Nonsquamous Non-Small Cell Neoplasm of Lung; Non-Small Cell Lung Cancer Metastatic; Non-Small Cell Lung Cancer Stage IIIB	Drug: Pemetrexed	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed After Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Pemetrexed 500 milligrams per square meter (mg/m^2) pemetrexed administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Maintenance therapy administered until disease progression or the participant is discontinued for any other reason. The first dose of maintenance therapy will be administered at the hospital; thereafter, therapy will be administered in the home setting by qualified oncology homecare nurses.

Drug: Pemetrexed; Administered intravenously; Other Names: LY231514 Alimta Pemetrexed disodium Pemetrexed sodium hydrate

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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).

4. 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".

5. 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".

6. 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".

7. 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".

8. 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".

9. 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.

10. 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.

11. 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.

12. 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.

13. 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).

14. 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.

Other Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Linkoping		Sweden	58185
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Solna		Sweden	17176
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London	Greater London	United Kingdom	SE1 9RT
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Maidstone	Kent	United Kingdom	ME16 9QQ
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nottingham	Nottinghamshire	United Kingdom	NG5 1PD
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aberdeen	Scotland	United Kingdom	AB25 2ZN
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Huddersfield	West Yorkshire	United Kingdom	HD3 3EA
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Birmingham		United Kingdom	B95SS
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01473563
• Other Study ID Numbers: 14079; H3E-EW-S133
• First Posted: Nov 17, 2011
• Last Update Posted: Oct 6, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pemetrexed

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (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.
Period Title: Overall Study
STARTED	52
Received at Least 1 Dose of Study Drug	52
COMPLETED	51
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Overall Participants	52
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66.0 (12.05)
Sex: Female, Male (Count of Participants)
Female	26 50%
Male	26 50%
Race/Ethnicity, Customized (participants) [Number]
White	48 92.3%
Black or African American	4 7.7%
Region of Enrollment (participants) [Number]
United Kingdom	43 82.7%
Sweden	9 17.3%
Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
0: Fully Active	14 26.9%
1: Restricted	38 73.1%
Most Recent Pathological Diagnosis (participants) [Number]
Adenocarcinoma, Lung	48 92.3%
Adenocarcinoma, Mucinous, No Other Symptoms (NOS)	1 1.9%
Adenocarcinoma, Moderately Differentiated, Lung	1 1.9%
Carcinoma, Non-Small Cell, Lung NOS	2 3.8%
Basis for Most Recent Pathological Diagnosis (participants) [Number]
Cytological	10 19.2%
Histopathological	42 80.8%
Stage of Disease (participants) [Number]
Stage IIIB	3 5.8%
Stage IV	48 92.3%
Stage IIIA	1 1.9%
Prior Systemic Therapy (participants) [Number]
Carboplatin + Gemcitabine	9 17.3%
Carboplatin + Pemetrexed	19 36.5%
Cisplatin + Pemetrexed	20 38.5%
Platinum-Based Therapy + Pemetrexed	4 7.7%
Best Response to Prior Systemic Therapy (participants) [Number]
Partial Response (PR)	25 48.1%
Stable Disease (SD)	26 50%
Progressive Disease (PD)	1 1.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Adhered to Treatment Administration at Home
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	52
Cycle 1, Hospital Delivery	100 192.3%
Cycle 2, Home Delivery	98.0 188.5%
Cycle 3, Home Delivery	98.0 188.5%
Cycle 4, Home Delivery	98.0 188.5%
Cycle 5, Home Delivery	98.0 188.5%
Cycle 6, Home Delivery	98.0 188.5%
Cycle 7, Home Delivery	90.7 174.4%
Cycle 8, Home Delivery	90.7 174.4%
Cycle 9, Home Delivery	90.7 174.4%
Cycle 10, Home Delivery	90.7 174.4%
Cycle 11, Home Delivery	90.7 174.4%
Cycle 12, Home Delivery	90.7 174.4%
Cycle 13, Home Delivery	90.7 174.4%
Cycle 14, Home Delivery	90.7 174.4%
Cycle 15, Home Delivery	90.7 174.4%
Cycle 16, Home Delivery	90.7 174.4%
Cycle 17, Home Delivery	90.7 174.4%
Cycle 18, Home Delivery	90.7 174.4%
Cycle 19, Home Delivery	90.7 174.4%

2. Secondary Outcome

Title	Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	34
Cycle 2 (n=34)	3.0 (18.6)
Cycle 4 (n=20)	7.7 (21.7)
30 days post treatment discontinuation (n=22)	-0.9 (18.9)

3. Secondary Outcome

Title	Change From Baseline in the EQ-5D Index Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	38
Cycle 2 (n=38)	0.03 (0.22)
Cycle 4 (n=23)	0.08 (0.22)
30 days post treatment discontinuation (n=26)	-0.9 (0.28)

4. Secondary Outcome

Title	Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Description	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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	43
Loss of Appetite (n=43)	16.3 (22.0)
Fatigue (n=43)	24.5 (27.2)
Cough (n=41)	9.2 (19.7)
Dyspnea (n=41)	17.2 (26.7)
Hemoptysis (n=43)	0.4 (4.3)
Pain (n=40)	11.8 (25.1)
Overall Symptomatic Distress (n=43)	8.3 (22.3)
Interference With Activity Level (n=43)	15.3 (25.1)
Overall Quality of Life (n=41)	12.2 (23.0)

5. Secondary Outcome

Title	Participant Satisfaction: Chemotherapy at Hospital
Description	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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	39
Q1, Support from other patients	8 15.4%
Q1, Access to other medical specialists	19 36.5%
Q1, Access to more technical services	12 23.1%
Q1, Safer in case something goes wrong	19 36.5%
Q1, Other	3 5.8%
Q2, Need to travel	36 69.2%
Q2, Having to wait for treatment	27 51.9%
Q2, Not having a personalized treatment	5 9.6%
Q2, Lack of privacy on the ward	7 13.5%
Q2, Other	1 1.9%
Q3, Very dissatisfied	0 0%
Q3, Somewhat dissatisfied	3 5.8%
Q3, Neither satisfied nor dissatisfied	3 5.8%
Q3, Somewhat satisfied	11 21.2%
Q3, Very satisfied	21 40.4%
Q4, Very dissatisfied	3 5.8%
Q4, Somewhat dissatisfied	0 0%
Q4, Neither satisfied nor dissatisfied	0 0%
Q4, Somewhat satisfied	3 5.8%
Q4, Very satisfied	32 61.5%

6. Secondary Outcome

Title	Participant Satisfaction: Chemotherapy at Home
Description	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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	39
Q5, No need to travel	37 71.2%
Q5, Not having to wait for treatment	27 51.9%
Q5, Personalized service	28 53.8%
Q5, More privacy	20 38.5%
Q5, Other	2 3.8%
Q6, Lack of other patients' support	5 9.6%
Q6, Extra burden for family/friends	1 1.9%
Q6, Safety concerns	4 7.7%
Q6, Need to rely on 1 medical specialist	7 13.5%
Q6, Other	19 36.5%
Q7, Very dissatisfied	1 1.9%
Q7, Somewhat dissatisfied	0 0%
Q7, Neither satisfied nor dissatisfied	2 3.8%
Q7, Somewhat satisfied	1 1.9%
Q7, Very Satisfied	30 57.7%

7. Secondary Outcome

Title	Participant Satisfaction: Regarding the Study Nurse
Description	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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	38
Q8, Yes	37 71.2%
Q8, No	0 0%
Q9, Yes	36 69.2%
Q9, No	1 1.9%
Q10, Yes	37 71.2%
Q10, No	1 1.9%
Q11, Yes	36 69.2%
Q11, No	0 0%
Q12, Yes	34 65.4%
Q12, No	0 0%
Q12, Uncertain	3 5.8%
Q13, Hardly any reassurance and support	0 0%
Q13, Some reassurance and support	2 3.8%
Q13, A lot of reassurance and support	35 67.3%
Q14, Very dissatisfied	3 5.8%
Q14, Somewhat dissatisfied	0 0%
Q14, Neither satisfied nor dissatisfied	1 1.9%
Q14, Somewhat satisfied	1 1.9%
Q14, Very satisfied	33 63.5%

8. Secondary Outcome

Title	Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Description	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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	38
Q15, Home	33 63.5%
Q15, Hospital	0 0%
Q15, Indifferent	5 9.6%
Q16, Yes	37 71.2%
Q16, No	0 0%
Q16, Not sure	0 0%

9. Secondary Outcome

Title	Physician Satisfaction: Distant Management of Participant
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	31
Very Dissatisfied	2
Somewhat Dissatisfied	1
Neither Satisfied Nor Dissatisfied	0
Somewhat Satisfied	8
Very Satisfied	20

10. Secondary Outcome

Title	Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources
Description	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)

Outcome Measure Data

Analysis Population Description

ITT population: Participants who received at least 1 dose of study drug.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	52
Number [participants]	29 55.8%

11. Secondary Outcome

Title	Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
Description	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)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	29
1 Unplanned Visit, Any Resource	8 15.4%
2 Unplanned Visits, Any Resource	6 11.5%
3 Unplanned Visits, Any Resource	5 9.6%
4 Unplanned Visits, Any Resource	2 3.8%
5 Unplanned Visits, Any Resource	3 5.8%
9 Unplanned Visits, Any Resource	1 1.9%
10 Unplanned Visits, Any Resource	1 1.9%
13 Unplanned Visits, Any Resource	1 1.9%
1 Unplanned Visit, Accident and Emergency Dept.	7 13.5%
2 Unplanned Visits, Accident and Emergency Dept.	2 3.8%
3 Unplanned Visits, Accident and Emergency Dept.	2 3.8%
1 Unplanned Visit, Specialist	9 17.3%
2 Unplanned Visits, Specialist	3 5.8%
5 Unplanned Visits, Specialist	1 1.9%
1 Unplanned Visit, GP or Family Doctor	6 11.5%
2 Unplanned Visits, GP or Family Doctor	3 5.8%
3 Unplanned Visits, GP or Family Doctor	2 3.8%
4 Unplanned Visits, GP or Family Doctor	3 5.8%
1 Unplanned Visit, Diagnostic procedures	6 11.5%
2 Unplanned Visits, Diagnostic procedures	2 3.8%
3 Unplanned Visits, Diagnostic procedures	3 5.8%
4 Unplanned Visits, Diagnostic procedures	1 1.9%

12. Other Pre-specified Outcome

Title	Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
Description	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]

Outcome Measure Data

Analysis Population Description

Safety Population: Participants who received at least 1 dose of study drug.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	52
At least 1 TEAE	51 98.1%
At least 1 Serious TEAE	21 40.4%
Death, AE (fell, multiple injuries)	1 1.9%
Death, Study Drug Toxicity (atypical pneumonia)	1 1.9%
Death, Study Disease	26 50%

13. Secondary Outcome

Title	Resource Utilization: Duration of Health Care Visits
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	42
Cycle 2 (n=42)	1.67 (0.493)
Cycle 3 (n=35)	1.66 (0.683)
Cycle 4 (n=28)	1.57 (0.311)

14. Secondary Outcome

Title	Resource Utilization: Distances Traveled
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	32
Cycle 1, Home to Hospital, Great Britain (n=25)	19.7 (23.39)
Cycle 1, Home to Hospital, Sweden (n=7)	30.7 (23.08)
Cycle 2, Hospital to Home, Great Britain (n=24)	15.5 (13.12)
Cycle 2, Hospital to Home, Sweden (n=7)	23.9 (23.93)
Cycle 3, Hospital to Home, Great Britain (n=11)	23.8 (16.72)
Cycle 3, Hospital to Home, Sweden (n=4)	17.5 (17.97)
Cycle 4, Hospital to Home, Great Britain (n=7)	11.7 (8.75)
Cycle 4, Hospital to Home, Sweden (n=2)	24.5 (27.58)

15. Secondary Outcome

Title	Overall Survival (OS) at 6 Months
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	52
Number (95% Confidence Interval) [percentage of participants]	73 140.4%

16. Secondary Outcome

Title	Time to Treatment Failure (TTF)
Description	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)

Outcome Measure Data

Analysis Population Description

ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.

Arm/Group Title	Pemetrexed
Arm/Group Description	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.
Measure Participants	52
Median (95% Confidence Interval) [months]	3.0

Adverse Events

Time Frame	Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
Arm/Group Title	Pemetrexed
Arm/Group Description	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.
All Cause Mortality
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	23/52 (44.2%)
Blood and lymphatic system disorders
Anaemia	2/52 (3.8%)	2
Thrombocytopenia	1/52 (1.9%)	1
Cardiac disorders
Atrial flutter	1/52 (1.9%)	1
Cardiac arrest	1/52 (1.9%)	1
Gastrointestinal disorders
Constipation	1/52 (1.9%)	1
Nausea	1/52 (1.9%)	1
Stomatitis	1/52 (1.9%)	1
Vomiting	1/52 (1.9%)	1
General disorders
Chest discomfort	1/52 (1.9%)	1
Chest pain	2/52 (3.8%)	2
Device occlusion	1/52 (1.9%)	1
Infections and infestations
Atypical pneumonia	1/52 (1.9%)	1
Bronchitis	1/52 (1.9%)	2
Influenza	1/52 (1.9%)	1
Lower respiratory tract infection	3/52 (5.8%)	4
Pneumonia	2/52 (3.8%)	3
Sepsis	1/52 (1.9%)	1
Injury, poisoning and procedural complications
Fall	3/52 (5.8%)	3
Humerus fracture	1/52 (1.9%)	1
Multiple injuries	1/52 (1.9%)	1
Investigations
Blood creatinine increased	1/52 (1.9%)	1
Neutrophil count decreased	1/52 (1.9%)	1
Musculoskeletal and connective tissue disorders
Back pain	2/52 (3.8%)	2
Muscular weakness	1/52 (1.9%)	1
Nervous system disorders
Dizziness	1/52 (1.9%)	1
Headache	1/52 (1.9%)	1
Loss of consciousness	1/52 (1.9%)	1
Sensory loss	1/52 (1.9%)	1
Spinal cord compression	1/52 (1.9%)	1
Renal and urinary disorders
Haematuria	1/52 (1.9%)	1
Renal impairment	1/52 (1.9%)	1
Reproductive system and breast disorders
Pelvic pain	1/52 (1.9%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/52 (1.9%)	1
Dysphonia	1/52 (1.9%)	1
Dyspnoea	4/52 (7.7%)	4
Haemoptysis	1/52 (1.9%)	1
Hypoxia	1/52 (1.9%)	1
Pleural effusion	1/52 (1.9%)	1
Pulmonary fibrosis	1/52 (1.9%)	1
Skin and subcutaneous tissue disorders
Rash	1/52 (1.9%)	1
Other (Not Including Serious) Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	51/52 (98.1%)
Blood and lymphatic system disorders
Anaemia	12/52 (23.1%)	14
Eye disorders
Lacrimation increased	6/52 (11.5%)	6
Gastrointestinal disorders
Abdominal pain	4/52 (7.7%)	4
Constipation	8/52 (15.4%)	10
Diarrhoea	3/52 (5.8%)	4
Dyspepsia	3/52 (5.8%)	4
Nausea	17/52 (32.7%)	24
Stomatitis	4/52 (7.7%)	4
Vomiting	6/52 (11.5%)	8
General disorders
Chest pain	4/52 (7.7%)	4
Fatigue	20/52 (38.5%)	31
Influenza like illness	4/52 (7.7%)	4
Oedema peripheral	3/52 (5.8%)	4
Pain	3/52 (5.8%)	3
Pyrexia	5/52 (9.6%)	7
Infections and infestations
Bronchitis	3/52 (5.8%)	4
Lower respiratory tract infection	3/52 (5.8%)	3
Upper respiratory tract infection	3/52 (5.8%)	4
Injury, poisoning and procedural complications
Fall	4/52 (7.7%)	4
Investigations
Blood creatinine increased	5/52 (9.6%)	5
Metabolism and nutrition disorders
Decreased appetite	9/52 (17.3%)	10
Musculoskeletal and connective tissue disorders
Arthralgia	5/52 (9.6%)	8
Back pain	9/52 (17.3%)	9
Joint swelling	4/52 (7.7%)	4
Nervous system disorders
Dizziness	5/52 (9.6%)	5
Dysgeusia	3/52 (5.8%)	3
Headache	8/52 (15.4%)	11
Lethargy	9/52 (17.3%)	12
Peripheral sensory neuropathy	3/52 (5.8%)	3
Respiratory, thoracic and mediastinal disorders
Cough	12/52 (23.1%)	12
Dyspnoea	9/52 (17.3%)	10
Oropharyngeal pain	3/52 (5.8%)	4
Productive cough	7/52 (13.5%)	7
Skin and subcutaneous tissue disorders
Rash	4/52 (7.7%)	4

Limitations/Caveats

A thorough literature search revealed that no specific validated questionnaire was available to assess participant and physician satisfaction with home care or resource utilization, therefore specific questions were created by the sponsor for use.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.