A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemetrexed — DRUG
  Induction therapy 500 milligram per meter squared (mg/m\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
• Pemetrexed — DRUG
  Maintenance therapy 500 mg/m\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
• Paclitaxel — DRUG
  Induction therapy 200 mg/m\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
• Carboplatin — DRUG
  Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
• Bevacizumab — BIOLOGICAL
  Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
• Bevacizumab — BIOLOGICAL
  Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.

Study Details

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Key Dates

First listed

Sep 30, 2008

Start date

Dec 31, 2008

Status verified

Nov 2015

Primary completion

Apr 30, 2012

Completion

Dec 31, 2014

Study Design

Enrollment

939 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pem/Carbo/Bev
  Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
• Active Comparator: Pac/Carbo/Bev
  Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab

Primary Outcome Measure

Overall Survival [ Time Frame: Baseline to date of death from any cause (up to 37.06 months) ]

Locations (67)

Find similar trials in Fayetteville, AR

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