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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00102804




Registration number
NCT00102804
Ethics application status
Date submitted
1/02/2005
Date registered
2/02/2005
Date last updated
29/12/2014

Titles & IDs
Public title
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
H3E-MC-JMEN
Secondary ID [2] 0 0
5122
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Placebo
Other interventions - Best Supportive Care

Experimental: Pemetrexed and Best Supportive Care -

Placebo Comparator: Placebo and Best Supportive Care -


Treatment: Drugs: Pemetrexed
500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression

Treatment: Drugs: Placebo
IV administration, q 21 days

Other interventions: Best Supportive Care
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Time - PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Timepoint [1] 0 0
Randomization to measured PD or death from any cause (up to 41 months)
Secondary outcome [1] 0 0
Overall Survival (OS) Time - OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.
Timepoint [1] 0 0
Randomization to date of death from any cause (up to 41 months)
Secondary outcome [2] 0 0
Time to Objective Progressive Disease (TPD) - TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Timepoint [2] 0 0
Randomization to measured PD (up to 41 months)
Secondary outcome [3] 0 0
Time to Worsening of Symptoms (TWS) - TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
Timepoint [3] 0 0
Randomization to worsening of each LCSS item (up to 39 months)
Secondary outcome [4] 0 0
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate) - Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.
Timepoint [4] 0 0
Baseline to measured PD (up to 41 months)
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs) - Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Timepoint [5] 0 0
Baseline to study completion (up to 41 Months)
Secondary outcome [6] 0 0
Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS - The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
Timepoint [6] 0 0
Baseline through 30 days post discontinuation of study treatment (up to 39 Months)

Eligibility
Key inclusion criteria
- Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or
positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.

- Participants must have had 1 of the following induction therapies for treatment for
Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV
NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus
carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus
cisplatin.

- Participants must have received only 1 chemotherapeutic doublet lasting precisely 4
cycles.

- Induction regimens must be based on 21-day cycles.

- Documented evidence of a tumor response of complete response (CR), partial response
(PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of
induction therapy and the date of randomization. This response does not have to be
confirmed in order for the participant to be randomized. Positron emission tomography
(PET) scans and ultrasounds may not be used for lesion measurements for response
determination.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- With the exception of those chemotherapies listed as inclusion criterion, participants
will not be included if they have received prior systemic anticancer therapy
(including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any
other cancer.

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.

- Inability to comply with protocol or study procedures.

- A serious concomitant systemic disorder that would compromise the participant's
ability to complete the study.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
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. - Bankstown
Recruitment hospital [2] 0 0
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. - Coffs Harbour
Recruitment hospital [3] 0 0
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. - Kogarah
Recruitment hospital [4] 0 0
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. - Port Macquarie
Recruitment hospital [5] 0 0
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. - Nambour
Recruitment hospital [6] 0 0
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. - Townsville
Recruitment hospital [7] 0 0
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. - Ashford
Recruitment hospital [8] 0 0
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. - Frankston
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
4560 - Nambour
Recruitment postcode(s) [6] 0 0
4810 - Townsville
Recruitment postcode(s) [7] 0 0
5035 - Ashford
Recruitment postcode(s) [8] 0 0
VIC 3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
United States of America
State/province [2] 0 0
New Hampshire
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Brazil
State/province [8] 0 0
Ijui
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Varna
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Dalian
Country [14] 0 0
China
State/province [14] 0 0
Guang Zhou
Country [15] 0 0
China
State/province [15] 0 0
Hangzhou
Country [16] 0 0
China
State/province [16] 0 0
Ji Nan
Country [17] 0 0
China
State/province [17] 0 0
Nan Jing
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Brno
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Ostrava-Poruba
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Prague
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Hamm
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Magdeburg
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Greece
State/province [29] 0 0
Chania
Country [30] 0 0
Hungary
State/province [30] 0 0
Mosdos
Country [31] 0 0
Hungary
State/province [31] 0 0
Szombathely
Country [32] 0 0
India
State/province [32] 0 0
Banglagore
Country [33] 0 0
India
State/province [33] 0 0
Jaipur
Country [34] 0 0
India
State/province [34] 0 0
Mumbai
Country [35] 0 0
India
State/province [35] 0 0
P.O Ernakulam
Country [36] 0 0
India
State/province [36] 0 0
Trivandrum
Country [37] 0 0
Italy
State/province [37] 0 0
Bari
Country [38] 0 0
Italy
State/province [38] 0 0
Bologna
Country [39] 0 0
Italy
State/province [39] 0 0
Genova
Country [40] 0 0
Italy
State/province [40] 0 0
Livorno
Country [41] 0 0
Italy
State/province [41] 0 0
Messina
Country [42] 0 0
Italy
State/province [42] 0 0
Padova
Country [43] 0 0
Italy
State/province [43] 0 0
Pisa
Country [44] 0 0
Italy
State/province [44] 0 0
Rome
Country [45] 0 0
Italy
State/province [45] 0 0
Rozzano
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Netherlands
State/province [47] 0 0
Amsterdam
Country [48] 0 0
Netherlands
State/province [48] 0 0
Ede
Country [49] 0 0
Netherlands
State/province [49] 0 0
Zutphen
Country [50] 0 0
Netherlands
State/province [50] 0 0
Zwolle
Country [51] 0 0
Poland
State/province [51] 0 0
Poznan
Country [52] 0 0
Poland
State/province [52] 0 0
Warsaw
Country [53] 0 0
Romania
State/province [53] 0 0
Cluj-Napoca
Country [54] 0 0
Romania
State/province [54] 0 0
Oradea
Country [55] 0 0
Spain
State/province [55] 0 0
Alcoi
Country [56] 0 0
Spain
State/province [56] 0 0
Alcorcon
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Granada
Country [59] 0 0
Spain
State/province [59] 0 0
Mataró
Country [60] 0 0
Spain
State/province [60] 0 0
Murcia
Country [61] 0 0
Spain
State/province [61] 0 0
Palma De Mallorca
Country [62] 0 0
Spain
State/province [62] 0 0
Santa Cruz De Tenerife
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taipei
Country [64] 0 0
Turkey
State/province [64] 0 0
Ankara
Country [65] 0 0
Turkey
State/province [65] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best
supportive care versus placebo plus best supportive care in NSCLC. Participants must have
received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to
randomization (enrollment) into this trial.
Trial website
https://clinicaltrials.gov/show/NCT00102804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications