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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00940875
Ethics application status
Date submitted
6/07/2009
Date registered
16/07/2009
Date last updated
2/04/2015

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
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
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
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
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)
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
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
54
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
Trial website
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

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/NCT00940875