AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00961415
Phase
PHASE3
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    7.5mg/kg iv on day 1 of each 3-week cycle
  • cisplatin — DRUG
    75mg/m2 iv on day 1 of each 3-week cycle
  • pemetrexed — DRUG
    500mg/m2 iv on day 1 of each 3-week cycle

Study Details

This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.

Key Dates

First listed
Aug 19, 2009
Start date
Aug 31, 2009
Status verified
Jan 2016
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
376 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
  • Experimental: Part 2A
  • Active Comparator: Part 2B

Primary Outcome Measure

Progression Free Survival During Maintenance Treatment Phase [ Time Frame: Up to 21 months ]

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