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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01998919




Registration number
NCT01998919
Ethics application status
Date submitted
25/11/2013
Date registered
2/12/2013
Date last updated
13/01/2015

Titles & IDs
Public title
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Scientific title
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
Secondary ID [1] 0 0
MO18633
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 - placebo
Treatment: Drugs - gemcitabine
Treatment: Drugs - cisplatin
Treatment: Drugs - carboplatin

Experimental: Tarceva + gemcitabine/platinum -

Placebo comparator: Placebo + gemcitabine/platinum -


Treatment: Drugs: erlotinib [Tarceva]
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily

Treatment: Drugs: placebo
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

Treatment: Drugs: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles

Treatment: Drugs: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin

Treatment: Drugs: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
Timepoint [2] 0 0
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Secondary outcome [4] 0 0
Time to Progression
Timepoint [4] 0 0
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Secondary outcome [5] 0 0
Progression-Free Survival (PFS)
Timepoint [5] 0 0
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Date of randomization until date of death or date of last follow-up assessment

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
* measurable disease;
* no previous chemotherapy for non-small cell lung cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unstable systemic disease;
* any other malignancies in the last 5 years.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Campbelltown
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Liverpool
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangzhou
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
Indonesia
State/province [4] 0 0
Jakarta
Country [5] 0 0
Indonesia
State/province [5] 0 0
Jogjakarta
Country [6] 0 0
Indonesia
State/province [6] 0 0
Semarang
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Kyunggi-do
Country [8] 0 0
Philippines
State/province [8] 0 0
Manila
Country [9] 0 0
Philippines
State/province [9] 0 0
Metro Manila
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei
Country [11] 0 0
Thailand
State/province [11] 0 0
Bangkok

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
Trial website
https://clinicaltrials.gov/study/NCT01998919
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/NCT01998919