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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Objective Response Rate - Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Disease Control Rate - Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Duration of Response - Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall Survival - Overall survival was defined as the interval between the date of randomization to the date of death from any cause.
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Mean Change in Pulse Rate From Baseline - Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value
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 - Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
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 - Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.
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
Gender
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
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)
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/show/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
Other publications