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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01366131
First received: June 2, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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: April 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
Sponsors 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: April 7, 2014
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 April 15, 2014