Non-Small Cell Lung CancerPhase 3NCT00102804
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Pemetrexed in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 73 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 663 participants
- Where
- 73 sitesin 20 countries
- Study dates
- Mar 2005to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
73 sites in 20 countries.
73 sites in 20 countries
Italy9 sites
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Bari, 70126
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Bologna, 40100
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Genova, 16132
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Livorno, 57128
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Messina, 98122
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Padova, 35128
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Pisa, 56100
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Rome, 00168
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Rozzano, 20089
Australia8 sites
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Ashford, South Australia, 5035
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Bankstown, New South Wales, 2200
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Coffs Harbour, New South Wales, 2450
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Frankston, Victoria, VIC 3199
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Kogarah, New South Wales, 2217
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Nambour, Queensland, 4560
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Port Macquarie, New South Wales, 2444
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Townsville, Queensland, 4810
Spain8 sites
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Alcorcón, 28922
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Alcoy, 03804
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Barcelona, 08003
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Granada, 18014
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Mataró, 08304
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Murcia, 30008
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Palma de Mallorca, 07198
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Santa Cruz de Tenerife, 38320
China7 sites
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Beijing, 100730
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Dalian, 116023
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Guangzhou, 510080
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Hangzhou, 310016
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Jinan, 250012
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Nanjing, 210009
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Shanghai, 200025
United States6 sites
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Dallas, Texas, 75204
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Marshfield, Wisconsin, 54449
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Memphis, Tennessee, 38120
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Minneapolis, Minnesota, 55455
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Pittsburgh, Pennsylvania, 15213
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Portsmouth, New Hampshire, 03801
Germany5 sites
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Hamburg, D-20246
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Hamm, 59071
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Hanover, D-30625
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Magdeburg, D-39120
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Ulm, D-89081
India5 sites
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Banglagore, 560034
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Jaipur, 302017
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Mumbai, 400 026
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P.O Ernakulam, 682304
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Trivandrum, 695 011
Netherlands4 sites
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Amsterdam, 1105 AZ
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Ede, 6716 RP
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Zutphen, 7207 BA
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Zwolle, 80211 JW
Czechia3 sites
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Brno, 656 91
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Ostrava-Poruba, 708 52
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Prague, 128 08
Brazil2 sites
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Ijuí, 98700 000
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São Paulo, 01277-900
Bulgaria2 sites
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Sofia, 1527
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Varna, 9010
Greece2 sites
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Athens, 11527
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Chania, 73300
Hungary2 sites
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Mosdós, 7257
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Szombathely, H-9700
Poland2 sites
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Poznan, 60-569
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Warsaw, 02-781
Romania2 sites
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Cluj-Napoca, 3400
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Oradea, 3700
Turkey (Türkiye)2 sites
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Ankara, 06100
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Izmir, 35100
Austria1 site
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Vienna, 1130
Croatia1 site
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Zagreb, 10000
South Korea1 site
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Seoul, 139-706
Taiwan1 site
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Taipei, 112
About this study
Official 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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed, Placebo, Best Supportive Care
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression
PlaceboDrug
IV administration, q 21 days
Best Supportive CareOther
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed and Best Supportive Care | Experimental | Not described Receives: Drug: Pemetrexed; Other: Best Supportive Care |
| Placebo and Best Supportive Care | Placebo comparator | Not described Receives: Drug: Placebo; Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to measured PD or death from any cause (up to 41 months)
Secondary outcomes (6)
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.
Measured: Randomization to date of death from any cause (up to 41 months)
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.
Measured: Randomization to measured PD (up to 41 months)
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.
Measured: Randomization to worsening of each LCSS item (up to 39 months)
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.
Measured: Baseline to measured PD (up to 41 months)
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.
Measured: Baseline to study completion (up to 41 Months)
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.
Measured: Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102804
- Sponsor's protocol ID
- 5122
- Other IDs
- H3E-MC-JMEN
- Status last verified
- Dec 2014
- First submitted
- 1 Feb 2005
- Last updated
- 29 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.
PubMed 22336221Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
PubMed 22266043Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
PubMed 19767093
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00102804
- Acronym / sponsor ID
- 5122
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Feb 2005 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed and Best Supportive Care | Experimental | Drug: Pemetrexed, Other: Best Supportive Care |
| Placebo and Best Supportive Care | Placebo comparator | Drug: Placebo, Other: Best Supportive Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: LY231514, Alimta500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression | Drug | Pemetrexed and Best Supportive Care |
| PlaceboIV administration, q 21 days | Drug | Placebo and Best Supportive Care |
| Best Supportive CareTreatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician. | Other | Pemetrexed and Best Supportive Care, Placebo and Best Supportive Care |
Primary outcome
Progression-Free Survival (PFS) Time
Time frame: Randomization to measured PD or death from any cause (up to 41 months)
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.
6 secondary outcomes
Overall Survival (OS) Time
Time frame: Randomization to date of death from any cause (up to 41 months)
Time to Objective Progressive Disease (TPD)
Time frame: Randomization to measured PD (up to 41 months)
Time to Worsening of Symptoms (TWS)
Time frame: Randomization to worsening of each LCSS item (up to 39 months)
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
Time frame: Baseline to measured PD (up to 41 months)
Number of Participants With Adverse Events (AEs)
Time frame: Baseline to study completion (up to 41 Months)
Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
Time frame: Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22336221Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.
- Derived from this study: PubMed 22266043Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
- Derived from this study: PubMed 19767093Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
73 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pemetrexed in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 73 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Italy, Australia, Spain, China, United States and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Time (time frame: Randomization to measured PD or death from any cause (up to 41 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102804, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2014.