Clinical trial NCT01366131: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
timeFrame: Up to 24 months
measure: 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)
timeFrame: Up to 24 months
measure: Overall survival (defined as the time from randomization until death from any cause)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Santa Monica
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Burnsville
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Vancouver
country: United States
state: Washington
city: St. Leonards
country: Australia
state: New South Wales
city: Herston
country: Australia
state: Queensland
city: Woodville South
country: Australia
state: South Australia
city: Brno
country: Czech Republic
city: Ostrava - Poruba
country: Czech Republic
city: Le Mans
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Paris
country: France
city: Saint Herblain
country: France
city: Toulouse
country: France
city: Essen
country: Germany
city: Gauting
country: Germany
city: Grosshansdorf
country: Germany
city: Halle
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Szekesfehervar
country: Hungary
city: Tatabánya
country: Hungary
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
Study officials:
affiliation: Genentech, Inc.
name: Ina Rhee, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.