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)
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01366131
First received: June 2, 2011
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: carboplatin Drug: MEGF0444A Drug: paclitaxel Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- 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) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Overall survival (defined as the time from randomization until death from any cause) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: MEGF0444A
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
|
| Experimental: B |
Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366131
Show 42 Study Locations
Show 42 Study LocationsSponsors and Collaborators
Genentech
Investigators
| Study Director: | Ina Rhee, M.D., Ph.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01366131 History of Changes |
| Other Study ID Numbers: | MEF4984g, GO27811 |
| Study First Received: | June 2, 2011 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Bevacizumab Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013