Brief Summary

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,713

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach

26 countries

126 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

3.7 years study duration

Study Start

First participant enrolled

July 1, 2004

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

July 12, 2004

Last Update Submit

September 10, 2019

Conditions

Non Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall survival
baseline to date of death from any cause

Secondary Outcomes (4)

Progression free survival
baseline to measured progressive disease
Time to progressive disease
baseline to measured progressive disease
Duration of response
time of response to progressive disease
Time to treatment failure
baseline to stopping treatment

Study Arms (2)

A

EXPERIMENTAL

Drug: pemetrexedDrug: cisplatin

B

ACTIVE COMPARATOR

Drug: gemcitabineDrug: cisplatin

Interventions

pemetrexedDRUG

500 mg/m2, IV q 21 days x 6 cycles

Also known as: LY231514, Alimta

gemcitabineDRUG

1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles

Also known as: LY188011, Gemzar

cisplatinDRUG

75 mg/m2, IV, q 21 days x 6 cycles

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
No prior chemotherapy for lung cancer.
Patients must have at least one uni-dimensionally measurable lesion.
Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

You may not qualify if:

Treatment with any drug within the last 30 days that has not received regulatory approval.
Serious cardiac condition.
Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Presence of fluid retention that cannot be controlled by drainage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (134)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Sacramento, California, United States

Location

Torrance, California, United States

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Jacksonville, Florida, United States

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Macon, Georgia, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Scarborough, Maine, United States

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Duluth, Minnesota, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Hackensack, New Jersey, United States

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Hickory, North Carolina, United States

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Portland, Oregon, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Bahía Blanca, Argentina

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Buenos Aires, Argentina

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Bedford Park, Australia

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Camperdown, Australia

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Chermisdie, Australia

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Fitzroy, Australia

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Hornsby, Australia

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Nedlands, Australia

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South Brisbane, Australia

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St Leonards, Australia

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Graz, Austria

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Grimmenstein, Austria

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Innsbruck, Austria

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Leoben, Austria

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Linz, Austria

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Sankt Pölten, Austria

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Vienna, Austria

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Wels, Austria

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Leuven, Belgium

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Liège, Belgium

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Florianópolis, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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North Vancouver, British Columbia, Canada

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Brampton, Ontario, Canada

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Toronto, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Herlev, Denmark

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Odense, Denmark

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Helsinki, Finland

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Tampere, Finland

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Bordeaux, France

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Grenoble, France

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Marseille, France

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Montpellier, France

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Paris, France

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Saint-Herblain, France

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Strasbourg, France

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Vandœuvre-lès-Nancy, France

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Mannheim, Germany

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Athens, Greece

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Heraklion, Greece

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Pátrai, Greece

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Budapest, Hungary

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Deszk, Hungary

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Pécs, Hungary

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Bangalore, India

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Hyderabad, India

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Kochi, India

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Mumbai, India

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New Dehli, India

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Pune, India

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Kfar Saba, Israel

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Tel Aviv, Israel

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Tel Litwinsky, Israel

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Ancona, Italy

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Bergamo, Italy

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Bologna, Italy

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Forlì, Italy

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Genova, Italy

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Livorno, Italy

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Modena, Italy

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Orbassano, Italy

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Roma, Italy

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Taormina, Italy

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Ciudad Obregón, Mexico

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Guadalajara, Mexico

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León, Mexico

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Mexicali, Mexico

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Mexico City, Mexico

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's-Hertogenbosch, Netherlands

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Alkmaar, Netherlands

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Amstelveen, Netherlands

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Amsterdam, Netherlands

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Arnhem, Netherlands

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Eindhoven, Netherlands

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Harderwijk, Netherlands

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Heerlen, Netherlands

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Krakow, Poland

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Lodz, Poland

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Szczecin-Zdunowo, Poland

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Warsaw, Poland

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Coimbra, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Santa Maria da Feira, Portugal

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San Juan, Puerto Rico

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Goyang-si, South Korea

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Seoul, South Korea

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Alicante, Spain

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Badalona, Spain

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Barcelona, Spain

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Madrid, Spain

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Pamplona, Spain

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Sabadell, Spain

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Santander, Spain

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Zaragoza, Spain

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Gothenburg, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Niao Sung Hsiang, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Bangor, United Kingdom

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Chelmsford, United Kingdom

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Fulham, United Kingdom

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Plymouth, United Kingdom

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Sutton, United Kingdom

Location

Related Publications (2)

Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.
PMID: 25082564DERIVED
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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedGemcitabineCisplatin

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, DicarboxylicDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 12, 2004

First Posted

July 16, 2004

Study Start

July 1, 2004

Primary Completion

January 1, 2007

Study Completion

March 1, 2008

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AR(2)BE(2)ME(5)CA(4)NL(8)US(18)DE(1)DK(2)IN(6)FI(2)HU(3)FR(8)PL(4)KR(2)TU(4)IL(3)PT(4)SE(3)PR(1)AU(8)IT(10)ES(8)GB(6)BR(5)GR(3)TW(4)

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (134)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (134)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations