Non Small Cell Lung CarcinomaPhase 3NCT00087711

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

A Phase 3 study testing pemetrexed, gemcitabine and cisplatin in people with Non Small Cell Lung Carcinoma, run by Eli Lilly and Company at 134 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Carcinoma
What is being tested?: pemetrexed, gemcitabine and cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,713 participants
Where: 134 sitesin 27 countries
Study dates: Jul 2004to Mar 2008
Phase: Phase 3
Are there results?: None posted in the registry

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

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.

Who cannot join

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.

Trial locations and contacts

134 sites in 27 countries.

Country

City, postcode or hospital

134 sites in 27 countries

United States18 sites

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Arlington, Texas
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Billings, Montana
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Columbia, South Carolina
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Duluth, Minnesota
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Hackensack, New Jersey
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Hickory, North Carolina
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Jacksonville, Florida
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Lexington, Kentucky
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Macon, Georgia
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Nashville, Tennessee
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Portland, Oregon
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Richmond, Virginia
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Sacramento, California
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Scarborough, Maine
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Seattle, Washington
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St Louis, Missouri
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Torrance, California
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Wichita, Kansas

Other trials in United States

Italy10 sites

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Ancona
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Bergamo
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Bologna
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Forlì
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Genova
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Livorno
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Modena
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Orbassano
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Roma
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Taormina

Other trials in Italy

Australia8 sites

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Bedford Park
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Camperdown
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Chermisdie
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Fitzroy
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Hornsby
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Nedlands
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South Brisbane
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St Leonards

Other trials in Australia

Austria8 sites

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Graz
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Grimmenstein
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Innsbruck
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Leoben
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Linz
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Sankt Pölten
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Vienna
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Wels

Other trials in Austria

France8 sites

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Bordeaux
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Grenoble
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Marseille
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Montpellier
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Paris
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Saint-Herblain
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Strasbourg
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Vandœuvre-lès-Nancy

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Netherlands8 sites

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's-Hertogenbosch
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Alkmaar
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Amstelveen
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Amsterdam
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Arnhem
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Eindhoven
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Harderwijk
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Heerlen

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Spain8 sites

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Alicante
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Badalona
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Barcelona
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Madrid
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Pamplona
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Sabadell
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Santander
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Zaragoza

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India6 sites

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Bangalore
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Hyderabad
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Kochi
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Mumbai
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New Dehli
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Pune

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United Kingdom6 sites

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Aberdeen
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Bangor
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Chelmsford
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Fulham
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Plymouth
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Sutton

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Brazil5 sites

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Florianópolis
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Porto Alegre
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Rio de Janeiro
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Salvador
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São Paulo

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Mexico5 sites

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Ciudad Obregón
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Guadalajara
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León
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Mexicali
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Mexico City

Other trials in Mexico

Canada4 sites

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Brampton, Ontario
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North Vancouver, British Columbia
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Sainte-Foy, Quebec
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Toronto, Ontario

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Poland4 sites

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Krakow
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Lodz
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Szczecin-Zdunowo
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Coimbra
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Lisbon
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Porto
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Niao Sung Hsiang
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Taichung
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Ankara
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Antalya
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Athens
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Heraklion
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Deszk
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Kfar Saba
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Tel Aviv
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Gothenburg
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Lund
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Leuven
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Liège

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Herlev
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About this study

Official title: A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions: Non Small Cell Lung Carcinoma
Being tested: pemetrexed, gemcitabine, cisplatin
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 mg/m2, IV q 21 days x 6 cycles
gemcitabineDrug
Also called LY188011, Gemzar
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
cisplatinDrug
75 mg/m2, IV, q 21 days x 6 cycles

Study groups in NCT00087711
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: pemetrexed; Drug: cisplatin
B	Active comparator	Not described Receives: Drug: gemcitabine; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
Measured: baseline to date of death from any cause

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Mar 2008

First posted16 Jul 2004 (estimated)
Study startJul 2004
Primary completionJan 2007
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CarcinomaStudies 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: None (open label)
Enrolment: 1,713 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087711
Sponsor's protocol ID: 2938
Other IDs: H3E-MC-JMDB
Status last verified: Sep 2019
First submitted: 12 Jul 2004
Last updated: 12 Sep 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

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.
PubMed 25082564
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.
PubMed 22266043

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non Small Cell Lung Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00087711
Acronym / sponsor ID: 2938
Conditions: Non Small Cell Lung Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,713 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Jan 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 16 Jul 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: pemetrexed, Drug: cisplatin
B	Active comparator	Drug: gemcitabine, Drug: cisplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

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 mg/m2, IV q 21 days x 6 cycles	Drug	A
gemcitabineAlso: LY188011, Gemzar1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles	Drug	B
cisplatin75 mg/m2, IV, q 21 days x 6 cycles	Drug	A, B

Primary outcome

Overall survival
Time frame: baseline to date of death from any cause

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Derived from this study: PubMed 25082564Wu 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.
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.
Lilly Clinical Trial RegistryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Related trials for Non Small Cell Lung Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

134 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pemetrexed, gemcitabine and cisplatin in people with Non Small Cell Lung Carcinoma, run by Eli Lilly and Company at 134 sites in 27 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 4 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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Italy, Australia, Austria, France and 22 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: baseline to date of death from any cause). 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 NCT00087711, which also lists 2 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 12 Sep 2019.