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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00520676




Registration number
NCT00520676
Ethics application status
Date submitted
22/08/2007
Date registered
24/08/2007
Date last updated
10/08/2011

Titles & IDs
Public title
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Scientific title
A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
H3E-CR-S380
Secondary ID [2] 0 0
11626
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: pemetrexed plus carboplatin - Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum

Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum

Active comparator: docetaxel plus carboplatin - Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum

Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum


Treatment: Drugs: pemetrexed
500 mg/m\^2, IV, q 21 days x 6 cycles maximum

Treatment: Drugs: docetaxel
75 mg/m\^2, IV, q 21 days x 6 cycles maximum

Treatment: Drugs: carboplatin
AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival Without Grade 3 or 4 Toxicity
Timepoint [1] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [3] 0 0
Percentage of Participants With Tumor Response (Response Rate)
Timepoint [3] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [4] 0 0
Survival Without Clinically Important Grade 3 or 4 Toxicity
Timepoint [4] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [5] 0 0
Survival Without Grade 4 Toxicity
Timepoint [5] 0 0
Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [6] 0 0
Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).

Eligibility
Key inclusion criteria
* Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
* Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
* Estimated life expectancy of at least 8 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected brain metastases
* Concurrent administration of any other tumor therapy
* Serious concomitant disorders
* Pregnancy or breast feeding
* Inability or unwillingness to take folic acid or vitamin B12 supplementation

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
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
VIC,WA
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ballarat
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wendouree
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) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bunbury
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3355 - Wendouree
Recruitment postcode(s) [4] 0 0
6230 - Bunbury
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Barretos
Country [2] 0 0
Brazil
State/province [2] 0 0
Goiania
Country [3] 0 0
Brazil
State/province [3] 0 0
Santo André
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Nanjing
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Suwon-City
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Ulsan
Country [11] 0 0
Mexico
State/province [11] 0 0
Ciudad Obregon
Country [12] 0 0
Mexico
State/province [12] 0 0
Durango
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexicali
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico City
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taichung
Country [16] 0 0
Taiwan
State/province [16] 0 0
Tao-Yuan

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 - 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

No information has been provided regarding IPD availability


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 are available at https://clinicaltrials.gov/study/NCT00520676