Study of Participants With Advanced Non-Small Cell Lung Cancer

Conditions

• Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemetrexed — DRUG
  Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
• Carboplatin — DRUG
  Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes.
• Paclitaxel — DRUG
  Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours
• Bevacizumab — BIOLOGICAL
  Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Study Details

The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Key Dates

First listed

Jul 29, 2009

Start date

Sep 1, 2009

Status verified

Oct 2021

Primary completion

Jan 31, 2013

Completion

Nov 6, 2020

Study Design

Enrollment

361 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pemetrexed + Carboplatin + Pemetrexed
  Pemetrexed and Carboplatin followed by Pemetrexed
• Active Comparator: Paclitaxel + Carboplatin + Bevacizumab
  Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab

Primary Outcome Measure

Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Randomization to measured progressive disease or treatment discontinuation up to 39.49 months ]

Locations (45)

Find similar trials in Scottsdale, AZ

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