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Completed

NCT Number: 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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Leonards, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEGF0444A

Drug

Intravenous repeating dose

Bevacizumab

Drug

Intravenous repeating dose

carboplatin

Drug

Intravenous repeating dose

paclitaxel

Drug

Intravenous repeating dose

Placebo

Drug

Intravenous repeating dose

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1

    Time frame: Up to 24 months

  2. 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

  3. Overall survival (defined as the time from randomization until death from any cause)

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
First posted
Jun 3, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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