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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00254891




Registration number
NCT00254891
Ethics application status
Date submitted
15/11/2005
Date registered
17/11/2005
Date last updated
30/03/2015

Titles & IDs
Public title
Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer
Scientific title
International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
A8501001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-3512676 + Paclitaxel + Carboplatin
Treatment: Drugs - Paclitaxel + Carboplatin

Experimental: A - Standard of care chemotherapy plus experiment intervention (PF-3512676)

Active comparator: B - Standard of care chemotherapy


Treatment: Drugs: PF-3512676 + Paclitaxel + Carboplatin
* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
* Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Treatment: Drugs: Paclitaxel + Carboplatin
* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
* Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
656 Events
Secondary outcome [1] 0 0
Overall Objective Response
Timepoint [1] 0 0
End of Treatment
Secondary outcome [2] 0 0
Time to Tumor Progression
Timepoint [2] 0 0
Time of progressive disease
Secondary outcome [3] 0 0
Progression Free Survival
Timepoint [3] 0 0
Time of primary endpoint
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Time of progressive disease
Secondary outcome [5] 0 0
Patient Reported Outcomes
Timepoint [5] 0 0
End of Treatment
Secondary outcome [6] 0 0
Overall Safety Profile
Timepoint [6] 0 0
28 days post PF-3512676 dosing

Eligibility
Key inclusion criteria
* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Small cell or carcinoid lung cancer
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases

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 3
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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
828
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Albury
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Pimlico
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Townsville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Woolloongabba
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Toorak Gardens
Recruitment hospital [9] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [10] 0 0
Pfizer Investigational Site - East Ringwood
Recruitment hospital [11] 0 0
Pfizer Investigational Site - Wodonga
Recruitment hospital [12] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4812 - Pimlico
Recruitment postcode(s) [5] 0 0
4814 - Townsville
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3135 - East Ringwood
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel
Trial website
https://clinicaltrials.gov/study/NCT00254891
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00254891