A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
• Docetaxel — DRUG
  Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
• Erlotinib — DRUG
  Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
• Pemetrexed — DRUG
  Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.

Study Details

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Key Dates

First listed

May 10, 2011

Start date

Jun 25, 2011

Status verified

Aug 2017

Primary completion

Jun 25, 2016

Completion

Jun 25, 2016

Study Design

Enrollment

485 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab + Standard of Care
  Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
• Active Comparator: Standard of Care
  Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to data cut-off date 24 June 2016 (approximately 5 years) ]

Locations (68)

Find similar trials in Mobile, AL

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