NCT00789373

Brief Summary

This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
939

participants targeted

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

Timeline
Completed

Started Nov 2008

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

Geographic Reach
15 countries

68 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

Study Start

First participant enrolled

November 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 18, 2011

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

November 10, 2008

Results QC Date

June 20, 2011

Last Update Submit

November 20, 2018

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Investigator-assessed Objective Progression-free Survival (PFS)

    Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

    Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Secondary Outcomes (9)

  • Independently-assessed Objective Progression-free Survival (PFS)

    Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)

  • Overall Survival (OS)

    Date of randomization to the date of death from any cause up to 39.5 months

  • Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

  • Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)

    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

  • Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)

    Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

  • +4 more secondary outcomes

Study Arms (2)

pemetrexed + cisplatin followed by pemetrexed

EXPERIMENTAL

pemetrexed plus cisplatin followed by pemetrexed plus best supportive care

Drug: PemetrexedDrug: CisplatinOther: Best Supportive Care

pemetrexed + cisplatin followed by placebo

PLACEBO COMPARATOR

pemetrexed plus cisplatin followed by placebo plus best supportive care

Drug: PemetrexedDrug: CisplatinDrug: PlaceboOther: Best Supportive Care

Interventions

PemetrexedDRUG

Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles

Also known as: Alimta, LY231514
pemetrexed + cisplatin followed by pemetrexedpemetrexed + cisplatin followed by placebo
CisplatinDRUG

Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles

pemetrexed + cisplatin followed by pemetrexedpemetrexed + cisplatin followed by placebo
PlaceboDRUG

Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation

pemetrexed + cisplatin followed by placebo
Best Supportive CareOTHER

Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).

pemetrexed + cisplatin followed by pemetrexedpemetrexed + cisplatin followed by placebo

Eligibility Criteria

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

You may qualify if:

  • You must sign an informed consent document for clinical research.
  • You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
  • You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
  • You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
  • You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.
  • Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.
  • You must be 18 years of age or older.
  • Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).

You may not qualify if:

  • You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer
  • You cannot have received other investigational drugs within the last 30 days of entering the trial.
  • You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
  • You cannot have other serious on-going illnesses including active infections.
  • You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
  • You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.
  • You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.
  • You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).
  • You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
  • You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.
  • You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
  • You cannot be pregnant or breastfeeding.
  • You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
  • You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. 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 patient to be randomized to the maintenance phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

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.

Adelaide, South Australia, 5000, Australia

Location

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Frankston, Victoria, 3199, Australia

Location

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Wendouree, Victoria, 3355, Australia

Location

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Aalst, 9300, Belgium

Location

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Brussels, 1200, Belgium

Location

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Genk, 3600, Belgium

Location

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Gilly, 6060, Belgium

Location

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Liège, 4000, Belgium

Location

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Sint-Niklaas, 9100, Belgium

Location

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Espoo, 02740, Finland

Location

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Helsinki, 00290, Finland

Location

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Tampere, 33520, Finland

Location

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Turku, 20520, Finland

Location

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Avignon, 84082, France

Location

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Dijon, 21034, France

Location

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Le Mans, 72037, France

Location

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Montpellier, F-34295, France

Location

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Nantes, 44202, France

Location

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Paris, 75015, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Frankfurt, 60596, Germany

Location

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Gerlingen, 70839, Germany

Location

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Großhansdorf, D-22927, Germany

Location

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Hamburg, D-20251, Germany

Location

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Heidelberg, 69126, Germany

Location

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Ulm, 89075, Germany

Location

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Athens, Greece

Location

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Chania, 73300, Greece

Location

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Neo Faliro, 18547, Greece

Location

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Pátrai, 26500, Greece

Location

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Bangalore, 560 078, India

Location

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Bhopal, 462001, India

Location

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Madurai, 625020, India

Location

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Mumbai, 400 012, India

Location

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Patna, 800 014, India

Location

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Avellino, 83100, Italy

Location

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Aviano, 33081, Italy

Location

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Genova, 16132, Italy

Location

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Lido di Camaiore, 55043, Italy

Location

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Monza, 20052, Italy

Location

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Pisa, 56100, Italy

Location

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Reggio Emilia, 42100, Italy

Location

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Rome, 00149, Italy

Location

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Udine, 33100, Italy

Location

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Ede, 6716 RP, Netherlands

Location

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Groningen, 9728 NT, Netherlands

Location

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Harderwijk, 3844 DG, Netherlands

Location

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Heerlen, 6419 PC, Netherlands

Location

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Poznan, 60-569, Poland

Location

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Warsaw, 02-781, Poland

Location

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Coimbra, 3040-853, Portugal

Location

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Lisbon, 1099-035, Portugal

Location

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Vila Franca de Xira, 4434-502, Portugal

Location

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Bucharest, 022328, Romania

Location

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Cluj-Napoca, 3400, Romania

Location

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Oradea, 3700, Romania

Location

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Manresa, 308243, Spain

Location

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Sabadell, 08208, Spain

Location

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Seville, 41013, Spain

Location

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Valencia, 46017, Spain

Location

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Zaragoza, 50009, Spain

Location

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Bornova, 35100, Turkey (Türkiye)

Location

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Sihhiye, 06100, Turkey (Türkiye)

Location

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Zeytinburnu, 034760, Turkey (Türkiye)

Location

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Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

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Guildford, Surrey, GU2 7XX, United Kingdom

Location

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Birmingham, West Midlands, B15 2TH, United Kingdom

Location

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Newcastle, NE7 7DN, United Kingdom

Location

Related Publications (8)

  • Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.

    PMID: 29424248DERIVED

  • Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.

    PMID: 25104617DERIVED

  • Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.

    PMID: 24419418DERIVED

  • Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.

    PMID: 23835707DERIVED

  • Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.

    PMID: 23328269DERIVED

  • Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.

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  • Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.

    PMID: 20211022DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedCisplatin

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, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

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

November 10, 2008

First Posted

November 11, 2008

Study Start

November 1, 2008

Primary Completion

June 1, 2010

Study Completion

November 1, 2017

Last Updated

December 14, 2018

Results First Posted

July 18, 2011

Record last verified: 2018-02

Locations

PT(3)PL(2)FR(7)FI(4)IN(5)NL(4)ES(5)IT(9)AU(3)DE(6)BE(6)TU(3)GR(4)GB(4)RO(3)