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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00940875




Registration number
NCT00940875
Ethics application status
Date submitted
6/07/2009
Date registered
15/07/2009
Date last updated
1/04/2015

Titles & IDs
Public title
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Scientific title
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.
Secondary ID [1] 0 0
ML22429
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 - erlotinib [Tarceva]
Treatment: Drugs - gemcitabine
Treatment: Drugs - gemcitabine

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: erlotinib [Tarceva]
150mg po on days 15-28 of each 4 week cycle

Treatment: Drugs: gemcitabine
1250mg/m2/day on days 1 and 8 of each 4 week cycle

Treatment: Drugs: gemcitabine
1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Disease Progression or Death - Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.
Timepoint [1] 0 0
BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
Primary outcome [2] 0 0
PFS - The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.
Timepoint [2] 0 0
BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0 - As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.
Timepoint [1] 0 0
BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
Secondary outcome [2] 0 0
Percentage of Participants With Non-Progression at Weeks 8 and 16 - Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.
Timepoint [2] 0 0
Weeks 8 and 16
Secondary outcome [3] 0 0
Percentage of Participants Who Died
Timepoint [3] 0 0
BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
Secondary outcome [4] 0 0
Overall Survival (OS) - OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.
Timepoint [4] 0 0
BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
Secondary outcome [5] 0 0
Duration of Response - Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.
Timepoint [5] 0 0
BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.

Eligibility
Key inclusion criteria
- adult patients, >=70 years of age or with ECOG PS of 2;

- advanced (stage IIIB or IV)non-small cell lung cancer;

- no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis
targeted drugs.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- active brain metastasis or spinal cord suppression;

- unstable systemic disease.

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Port Macquarie
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Tweed Heads
Recruitment hospital [5] 0 0
- Wollongong
Recruitment hospital [6] 0 0
- Brisbane
Recruitment hospital [7] 0 0
- Greenslopes
Recruitment hospital [8] 0 0
- Woolloongabba
Recruitment hospital [9] 0 0
- Richmond
Recruitment hospital [10] 0 0
- Terrace Gardens
Recruitment hospital [11] 0 0
- Hobart
Recruitment hospital [12] 0 0
- Bendigo
Recruitment hospital [13] 0 0
- Heidelberg
Recruitment hospital [14] 0 0
- Melbourne
Recruitment hospital [15] 0 0
- Wodonga
Recruitment hospital [16] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2139 - Sydney
Recruitment postcode(s) [4] 0 0
2747 - Sydney
Recruitment postcode(s) [5] 0 0
NSW 2485 - Tweed Heads
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4120 - Greenslopes
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
3121 - Richmond
Recruitment postcode(s) [11] 0 0
5065 - Terrace Gardens
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3550 - Bendigo
Recruitment postcode(s) [14] 0 0
3084 - Heidelberg
Recruitment postcode(s) [15] 0 0
3002 - Melbourne
Recruitment postcode(s) [16] 0 0
3690 - Wodonga
Recruitment postcode(s) [17] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva
and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients,
or patients with ECOG performance status of 2, with advanced non-small cell lung
cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on
days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine
monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00940875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00940875