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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/NCT01366131




Registration number
NCT01366131
Ethics application status
Date submitted
2/06/2011
Date registered
3/06/2011
Date last updated
2/11/2016

Titles & IDs
Public title
Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)
Scientific title
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease
Secondary ID [1] 0 0
GO27811
Secondary ID [2] 0 0
MEF4984g
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 - MEGF0444A
Treatment: Drugs - bevacizumab
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - placebo

Experimental: A -

Experimental: B -


Treatment: Drugs: MEGF0444A
Intravenous repeating dose

Treatment: Drugs: bevacizumab
Intravenous repeating dose

Treatment: Drugs: carboplatin
Intravenous repeating dose

Treatment: Drugs: paclitaxel
Intravenous repeating dose

Treatment: Drugs: placebo
Intravenous repeating dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Overall survival (defined as the time from randomization until death from any cause)
Timepoint [3] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
- Histologically or cytologically documented inoperable (Stage IV) or recurrent
non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that
are based on sputum cytology alone are not acceptable. Mixed tumors should be
categorized according to the predominant cell type.

- ECOG performance status of 0 or 1

- Life expectancy >12 weeks

- Measurable disease, as defined by RECIST 1.1

- Adequate hematologic and end organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase
inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy)
before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who
received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the
time interval from completion of adjuvant therapy until disease progression is > 12
months.

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days prior to enrollment

- Malignancies other than NSCLC within 5 years prior to randomization, except for
adequately treated carcinoma in situ of the cervix, basal or squamous cell skin
cancer, localized prostate cancer treated surgically with curative intent, ductal
carcinoma in situ treated surgically with curative intent

- Pregnant and lactating women

- Active infection requiring IV antibiotics

Bevacizumab-Specific Exclusions:

- Histologically or cytologically documented inoperable, locally advanced, mixed
non-small cell and small cell tumors or mixed adenosquamous carcinomas with a
predominant squamous component

- Evidence of tumor invading major blood vessels on imaging

- Evidence of central nervous system (CNS) metastases

- History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1

- Significant vascular disease within 6 months prior to Day 1

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1

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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Woodville South
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Brno
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Ostrava - Poruba
Country [19] 0 0
France
State/province [19] 0 0
Le Mans
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Saint Herblain
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Gauting
Country [27] 0 0
Germany
State/province [27] 0 0
Grosshansdorf
Country [28] 0 0
Germany
State/province [28] 0 0
Halle
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Hungary
State/province [30] 0 0
Szekesfehervar
Country [31] 0 0
Hungary
State/province [31] 0 0
Tatabánya
Country [32] 0 0
Poland
State/province [32] 0 0
Bydgoszcz
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed
to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin +
bevacizumab therapy in patients with histologically or cytologically documented inoperable,
locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01366131
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ina Rhee, M.D., Ph.D.
Address 0 0
Genentech, Inc.
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/NCT01366131