Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.
Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
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) - OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
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) - Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
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) - Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.
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 - Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
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 - Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
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) - Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The purpose of this study is to compare the combination of pemetrexed and carboplatin with
the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4
toxicity in previously untreated patients with locally advanced or metastatic non-small cell
lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/show/NCT00520676
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

Summary results
Other publications