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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00518011




Registration number
NCT00518011
Ethics application status
Date submitted
16/08/2007
Date registered
17/08/2007
Date last updated
16/05/2016

Titles & IDs
Public title
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Scientific title
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
Secondary ID [1] 0 0
ML20063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous 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
Treatment: Drugs - Gemcitabine

Experimental: Erlotinib + Gemcitabine - Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

Active comparator: Gemcitabine - Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.


Treatment: Drugs: Erlotinib
150 mg po daily

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Objective Response Rate
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Disease Control Rate
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Mean Change in Pulse Rate From Baseline
Timepoint [5] 0 0
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Secondary outcome [6] 0 0
Mean Change in Blood Pressure From Baseline
Timepoint [6] 0 0
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Secondary outcome [7] 0 0
Mean Change in Body Temperature From Baseline
Timepoint [7] 0 0
Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
* ECOG PS 2;
* adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior chemotherapy or systemic anti-tumor therapy;
* hypersensitivity to erlotinib;
* any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Chermside
Recruitment hospital [3] 0 0
- Footscray
Recruitment hospital [4] 0 0
- Greenslopes
Recruitment hospital [5] 0 0
- Lismore
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Parkville
Recruitment hospital [8] 0 0
- Randwick
Recruitment hospital [9] 0 0
- Richmond
Recruitment hospital [10] 0 0
- St. Leonards
Recruitment hospital [11] 0 0
- Sydney
Recruitment hospital [12] 0 0
- Wodonga
Recruitment hospital [13] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
2480 - Lismore
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment postcode(s) [7] 0 0
3084 - Melbourne
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
2031 - Randwick
Recruitment postcode(s) [10] 0 0
3121 - Richmond
Recruitment postcode(s) [11] 0 0
2065 - St. Leonards
Recruitment postcode(s) [12] 0 0
2139 - Sydney
Recruitment postcode(s) [13] 0 0
3690 - Wodonga
Recruitment postcode(s) [14] 0 0
2500 - Wollongong

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 assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00518011
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/study/NCT00518011