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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01666977




Registration number
NCT01666977
Ethics application status
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
3/06/2016

Titles & IDs
Public title
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
Scientific title
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2011-001111-31
Secondary ID [2] 0 0
20101128
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 - AMG 386
Treatment: Drugs - AMG 386
Treatment: Drugs - AMG 386 Placebo
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin

Experimental: Arm A - Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Experimental: Arm B - Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Experimental: Arm C - Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles


Treatment: Drugs: AMG 386
15mg/kg

Treatment: Drugs: AMG 386
30 mg/kg

Treatment: Drugs: AMG 386 Placebo
AMG 386 Placebo

Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg/m2

Treatment: Drugs: Carboplatin
Carboplatin AUC 6
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
Incidence of adverse events and clinical laboratory abnormalities defined as a DLT

Eligibility
Key inclusion criteria
- Histologically confirmed, unresectable stage IV non-squamous non small cell lung
cancer (NSCLC)

- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with
modifications

- Adequate hematological, renal, and hepatic function, normal coagulation profile,
calculated CrCL = 45 mL/min

- Other criteria may apply
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any prior chemotherapy or targeted therapy for non-squamous NSCLC

- Subjects with adenosquamous histology or any histology subtype containing greater than
10% squamous cells

- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to
treatment with a tyrosine kinase inhibitor (TKI)

- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations

- History or presence of central nervous system metastases

- Central (chest) radiation therapy within 28 days prior to enrollment/randomization,
radiation therapy to any other site(s) within 14 days prior to
enrollment/randomization

- History of pulmonary hemorrhage or gross hemoptysis within 6 months

- History of arterial or venous thromboembolism within 12 months

- History of clinically significant bleeding within 6 months

- Clinically significant cardiovascular disease within 12 months

- Other criteria may apply

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - Tweed Heads
Recruitment hospital [5] 0 0
Research Site - Herston
Recruitment hospital [6] 0 0
Research Site - Bentleigh East
Recruitment hospital [7] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Greece
State/province [12] 0 0
Heraklion
Country [13] 0 0
Greece
State/province [13] 0 0
Larissa
Country [14] 0 0
Greece
State/province [14] 0 0
Patra
Country [15] 0 0
Greece
State/province [15] 0 0
Thessaloniki
Country [16] 0 0
Spain
State/province [16] 0 0
Andalucía
Country [17] 0 0
Spain
State/province [17] 0 0
Aragón
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug
measuring progression free survival.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01666977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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/ct2/show/NCT01666977