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)

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366131
• Other study ID #: MEF4984g
• Secondary ID: GO27811
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2011
• Last updated: November 1, 2016
• Start date: June 2011

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• MEGF0444A
Intravenous repeating dose
• bevacizumab
Intravenous repeating dose
• carboplatin
Intravenous repeating dose
• paclitaxel
Intravenous repeating dose
• placebo
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  France,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 24 months	No
Secondary	Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1		Up to 24 months	No
Secondary	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)		Up to 24 months	No
Secondary	Overall survival (defined as the time from randomization until death from any cause)		Up to 24 months	No