NCT00102804

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
663

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
19 countries

72 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2005

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
Last Updated

December 29, 2014

Status Verified

December 1, 2014

Enrollment Period

2.4 years

First QC Date

February 1, 2005

Results QC Date

December 17, 2014

Last Update Submit

December 17, 2014

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Randomization to measured PD or death from any cause (up to 41 months)

Secondary Outcomes (6)

  • Overall Survival (OS) Time

    Randomization to date of death from any cause (up to 41 months)

  • Time to Objective Progressive Disease (TPD)

    Randomization to measured PD (up to 41 months)

  • Time to Worsening of Symptoms (TWS)

    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)

    Baseline to measured PD (up to 41 months)

  • Number of Participants With Adverse Events (AEs)

    Baseline to study completion (up to 41 Months)

  • +1 more secondary outcomes

Study Arms (2)

Pemetrexed and Best Supportive Care

EXPERIMENTAL
Drug: PemetrexedOther: Best Supportive Care

Placebo and Best Supportive Care

PLACEBO COMPARATOR
Drug: PlaceboOther: Best Supportive Care

Interventions

PemetrexedDRUG

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

Also known as: LY231514, Alimta
Pemetrexed and Best Supportive Care
PlaceboDRUG

IV administration, q 21 days

Placebo and Best Supportive Care
Best Supportive CareOTHER

Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Pemetrexed and Best Supportive CarePlacebo and Best Supportive Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (73)

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.

Minneapolis, Minnesota, 55455, United States

Location

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Portsmouth, New Hampshire, 03801, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Dallas, Texas, 75204, United States

Location

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Marshfield, Wisconsin, 54449, United States

Location

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Bankstown, New South Wales, 2200, Australia

Location

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Coffs Harbour, New South Wales, 2450, Australia

Location

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Kogarah, New South Wales, 2217, Australia

Location

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Port Macquarie, New South Wales, 2444, Australia

Location

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Nambour, Queensland, 4560, Australia

Location

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Townsville, Queensland, 4810, Australia

Location

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Ashford, South Australia, 5035, Australia

Location

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Frankston, Victoria, VIC 3199, Australia

Location

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Vienna, 1130, Austria

Location

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Ijuí, 98700 000, Brazil

Location

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São Paulo, 01277-900, Brazil

Location

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Sofia, 1527, Bulgaria

Location

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Varna, 9010, Bulgaria

Location

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Beijing, 100730, China

Location

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Dalian, 116023, China

Location

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Guangzhou, 510080, China

Location

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Hangzhou, 310016, China

Location

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Jinan, 250012, China

Location

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Nanjing, 210009, China

Location

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Shanghai, 200025, China

Location

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Zagreb, 10000, Croatia

Location

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Brno, 656 91, Czechia

Location

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Ostrava-Poruba, 708 52, Czechia

Location

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Prague, 128 08, Czechia

Location

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Hamburg, D-20246, Germany

Location

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Hamm, 59071, Germany

Location

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Hanover, D-30625, Germany

Location

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Magdeburg, D-39120, Germany

Location

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Ulm, D-89081, Germany

Location

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Athens, 11527, Greece

Location

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Chania, 73300, Greece

Location

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Mosdós, 7257, Hungary

Location

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Szombathely, H-9700, Hungary

Location

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Banglagore, 560034, India

Location

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Jaipur, 302017, India

Location

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Mumbai, 400 026, India

Location

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P.O Ernakulam, 682304, India

Location

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Trivandrum, 695 011, India

Location

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Bari, 70126, Italy

Location

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Bologna, 40100, Italy

Location

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Genova, 16132, Italy

Location

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Livorno, 57128, Italy

Location

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Messina, 98122, Italy

Location

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Padua, 35128, Italy

Location

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Pisa, 56100, Italy

Location

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Rome, 00168, Italy

Location

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Rozzano, 20089, Italy

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Ede, 6716 RP, Netherlands

Location

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Zutphen, 7207 BA, Netherlands

Location

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Zwolle, 80211 JW, Netherlands

Location

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Poznan, 60-569, Poland

Location

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Warsaw, 02-781, Poland

Location

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Cluj-Napoca, 3400, Romania

Location

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Oradea, 3700, Romania

Location

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Seoul, 139-706, South Korea

Location

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Alcorcón, 28922, Spain

Location

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Alcoy, 03804, Spain

Location

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Barcelona, 08003, Spain

Location

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Granada, 18014, Spain

Location

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Mataró, 08304, Spain

Location

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Murcia, 30008, Spain

Location

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Palma de Mallorca, 07198, Spain

Location

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Santa Cruz de Tenerife, 38320, Spain

Location

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Taipei, 112, Taiwan

Location

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Ankara, 06100, Turkey (Türkiye)

Location

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Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 22336221DERIVED

  • Gridelli 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.

    PMID: 22266043DERIVED

  • Ciuleanu 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.

    PMID: 19767093DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Limitations and Caveats

Four participants (pts) assigned to placebo received pemetrexed; pts analyzed for efficacy as randomized. Three treated pts did not sign ICF, 1 treated pt signed ICF but did not complete entire randomization process; pts excluded from all analyses.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2005

First Posted

February 2, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2007

Study Completion

December 1, 2013

Last Updated

December 29, 2014

Results First Posted

December 29, 2014

Record last verified: 2014-12

Locations

BR(2)CN(7)PL(2)KR(1)BU(2)DE(5)TU(2)US(6)NL(4)IN(5)GR(2)ES(8)IT(9)CR(1)RO(2)AU(8)CZ(3)TW(1)HU(2)