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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00087711




Registration number
NCT00087711
Ethics application status
Date submitted
12/07/2004
Date registered
16/07/2004

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
H3E-MC-JMDB
Secondary ID [2] 0 0
2938
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - pemetrexed
Treatment: Drugs - gemcitabine
Treatment: Drugs - cisplatin

Experimental: A -

Active comparator: B -


Treatment: Drugs: pemetrexed
500 mg/m2, IV q 21 days x 6 cycles

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

Treatment: Drugs: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
baseline to date of death from any cause
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
baseline to measured progressive disease
Secondary outcome [2] 0 0
Time to progressive disease
Timepoint [2] 0 0
baseline to measured progressive disease
Secondary outcome [3] 0 0
Duration of response
Timepoint [3] 0 0
time of response to progressive disease
Secondary outcome [4] 0 0
Time to treatment failure
Timepoint [4] 0 0
baseline to stopping treatment

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
1713
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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 - Bedford Park
Recruitment hospital [2] 0 0
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 - Camperdown
Recruitment hospital [3] 0 0
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 - Chermisdie
Recruitment hospital [4] 0 0
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 - Fitzroy
Recruitment hospital [5] 0 0
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 - Hornsby
Recruitment hospital [6] 0 0
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 - Nedlands
Recruitment hospital [7] 0 0
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 - South Brisbane
Recruitment hospital [8] 0 0
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 - St Leonards
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Chermisdie
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Hornsby
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment postcode(s) [7] 0 0
- South Brisbane
Recruitment postcode(s) [8] 0 0
- St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Florida
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Georgia
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Kansas
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United States of America
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Kentucky
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Maine
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Missouri
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Montana
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New Jersey
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North Carolina
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Oregon
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Bahia Blanca
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Argentina
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Buenos Aires
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Austria
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Graz
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Austria
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Grimmenstein
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Austria
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Innsbruck
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Leoben
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Austria
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Linz
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St. Poelten
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Vienna
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Austria
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Wels
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Florianopolis
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Brazil
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Porto Alegre
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Brazil
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Rio De Janeiro
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Brazil
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Herlev
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Odense
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Helsinki
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Saint Herblain
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Vandoeuvre-les-Nancy
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Mannheim
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Athens
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Patras
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Hungary
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Hungary
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Deszk
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Hungary
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Pecs
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India
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Bangalore
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India
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Cochin
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India
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Hyderabad
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India
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Mumbai
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India
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New Dehli
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India
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Pune
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Israel
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Kfar Saba
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Israel
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Tel-Aviv
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Israel
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Tel-Hashomer
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Italy
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Ancona
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Bergamo
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Bologna
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Forli
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Genova
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Livorno
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Modena
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Italy
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Orbassano
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Roma
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Italy
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Taormina
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Korea, Republic of
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Goyang-Si
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Korea, Republic of
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Seoul
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Ciudad Obregon
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Leon
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Mexico City
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Arnhem
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Krakow
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Lodz
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Coimbra
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Lund
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Stockholm
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Taipei
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Tao-Yuan
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Turkey
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Ankara
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Aberdeen
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United Kingdom
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Bangor
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United Kingdom
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Chelmsford
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United Kingdom
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Fulham
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United Kingdom
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Plymouth
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00087711