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
Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
376
12 countries
91
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2009
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedFebruary 22, 2016
January 1, 2016
1.7 years
August 18, 2009
November 30, 2015
January 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival During Maintenance Treatment Phase
Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Up to 21 months
Secondary Outcomes (7)
Overall Survival During Maintenance Treatment Phase
Up to 21 months
Best Overall Response Rate During Maintenance Treatment Phase
Up to 21 months
Duration of Response During Maintenance Treatment Phase
Up to 21 months
Duration of Disease Control During Maintenance Treatment Phase
Up to 21 months
Incidence of Adverse Events and Serious Adverse Event
Up to 21 months
- +2 more secondary outcomes
Study Arms (3)
Part 1
EXPERIMENTALPart 2A
EXPERIMENTALPart 2B
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adults \>/=18 years of age
- inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
- at least 1 measurable lesion meeting RECIST criteria
- ECOG performance status 0-2
- adequate hematological, liver and renal function
You may not qualify if:
- prior chemotherapy or treatment with another systemic anti-cancer agent
- 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 or DCIS
- evidence of tumor invading major blood vessels
- current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- history of haemoptysis \>/=grade 2
- clinically significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Unknown Facility
Béziers, 34500, France
Unknown Facility
Bordeaux, 33077, France
Unknown Facility
Bron, 69677, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Caen, 14076, France
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Gap, 05007, France
Unknown Facility
Gleizé, 69400, France
Unknown Facility
La Source, 45100, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87039, France
Unknown Facility
Lyon, 69317, France
Unknown Facility
Marseille, 13915, France
Unknown Facility
Nancy, 54100, France
Unknown Facility
Nîmes, 30900, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Saint-Priest-en-Jarez, 42770, France
Unknown Facility
Strasbourg, 67065, France
Unknown Facility
Toulon, 83041, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Augsburg, 86150, Germany
Unknown Facility
Bad Berka, 99437, Germany
Unknown Facility
Berlin, 13125, Germany
Unknown Facility
Bonn, 53113, Germany
Unknown Facility
Ebensfeld, 96250, Germany
Unknown Facility
Frankfurt, 60488, Germany
Unknown Facility
Freiburg im Breisgau, 79106, Germany
Unknown Facility
Gauting, 82131, Germany
Unknown Facility
Großhansdorf, 22927, Germany
Unknown Facility
Halle, 06120, Germany
Unknown Facility
Hamburg, 21075, Germany
Unknown Facility
Immenhausen, 34376, Germany
Unknown Facility
Karlsruhe, 76137, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
Minden, 32429, Germany
Unknown Facility
München, 80336, Germany
Unknown Facility
Oldenburg, 26121, Germany
Unknown Facility
Alexandroupoli, 68100, Greece
Unknown Facility
Lecce, Apulia, 73100, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Aviano, Friuli Venezia Giulia, 33081, Italy
Unknown Facility
Rome, Lazio, 00168, Italy
Unknown Facility
Novara, Piedmont, 28100, Italy
Unknown Facility
Sassari, Sardinia, 07100, Italy
Unknown Facility
Pisa, Tuscany, 56124, Italy
Unknown Facility
Padua, Veneto, 35128, Italy
Unknown Facility
's-Hertogenbosch, 5211 RW, Netherlands
Unknown Facility
Amersfoort, 3818 ES, Netherlands
Unknown Facility
Amsterdam, 1066 CX, Netherlands
Unknown Facility
Breda, 4818 CK, Netherlands
Unknown Facility
Eindhoven, 5623 EJ, Netherlands
Unknown Facility
Haarlem, 2035 RC, Netherlands
Unknown Facility
Nieuwegein, 3435 CM, Netherlands
Unknown Facility
Rotterdam, 3045 PM, Netherlands
Unknown Facility
Sittard-Geleen, 6162 BG, Netherlands
Unknown Facility
The Hague, 2504 LN, Netherlands
Unknown Facility
Zaandam, 1502 DV, Netherlands
Unknown Facility
Balashikha, 143900, Russia
Unknown Facility
Irkutsk, 664035, Russia
Unknown Facility
Krasnodar, 350086, Russia
Unknown Facility
Moscow, 115478, Russia
Unknown Facility
Saint Petersburg, 197089, Russia
Unknown Facility
Bundang City, 463-802, South Korea
Unknown Facility
Daegu, 700-712, South Korea
Unknown Facility
Gyeonggi-do, 410-769, South Korea
Unknown Facility
Seoul, 110746, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Seoul, 137-807, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Unknown Facility
Madrid, Madrid, 28034, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28046, Spain
Unknown Facility
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Unknown Facility
Gävle, 80187, Sweden
Unknown Facility
Linköping, 58185, Sweden
Unknown Facility
Lund, 22185, Sweden
Unknown Facility
Uppsala, 751 85, Sweden
Unknown Facility
Zurich, 8091, Switzerland
Unknown Facility
Antalya, 07070, Turkey (Türkiye)
Unknown Facility
Izmir, 35110, Turkey (Türkiye)
Unknown Facility
Al Ain City, 15258, United Arab Emirates
Related Publications (1)
Barlesi F, Scherpereel A, Rittmeyer A, Pazzola A, Ferrer Tur N, Kim JH, Ahn MJ, Aerts JG, Gorbunova V, Vikstrom A, Wong EK, Perez-Moreno P, Mitchell L, Groen HJ. Randomized phase III trial of maintenance bevacizumab with or without pemetrexed after first-line induction with bevacizumab, cisplatin, and pemetrexed in advanced nonsquamous non-small-cell lung cancer: AVAPERL (MO22089). J Clin Oncol. 2013 Aug 20;31(24):3004-11. doi: 10.1200/JCO.2012.42.3749. Epub 2013 Jul 8.
PMID: 23835708DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
February 22, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-01