This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01364012
First received: May 27, 2011
Last updated: July 26, 2017
Last verified: July 2017
May 27, 2011
July 26, 2017
May 23, 2011
August 30, 2017   (Final data collection date for primary outcome measure)
Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months) ]
Progression-free survival (PFS), tumour assessments according to RECIST criteria [ Time Frame: approximately 24 months ]
Complete list of historical versions of study NCT01364012 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Baseline up to death (up to approximately 35 months) ]
  • Percentage of Participants Who are Alive at Year 1 [ Time Frame: Year 1 ]
  • Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • Duration of Response as Assessed Using RECIST v1.0 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: From baseline up to approximately 35 months ]
  • PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor-A (VEGF-A) High/Low Level Expression at Baseline [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) High/Low Level Expression at Baseline [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline [ Time Frame: Baseline up to death (up to approximately 35 months) ]
  • OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline [ Time Frame: Baseline up to death (up to approximately 35 months) ]
  • Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) ]
  • Overall Survival (OS) [ Time Frame: approximately 48 months ]
  • 1-year survival rate [ Time Frame: approximately 30 months ]
  • Overall response rate (ORR): complete response + partial response [ Time Frame: approximately 24 months ]
  • Duration of response [ Time Frame: approximately 24 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 48 months ]
  • Correlation of baseline vascular endothelial growth factor (VEGF) plasma levels with clinical outcome (PFS/OS/ORR) [ Time Frame: approximately 48 months ]
Not Provided
Not Provided
 
A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy
A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin/Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy For Advanced Disease
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. After progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Bevacizumab
    Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
    Other Name: Avastin
  • Drug: Carboplatin
    Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.
  • Drug: Paclitaxel
    Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.
  • Drug: Placebo
    Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
  • Experimental: Bevacizumab + Paclitaxel/Carboplatin
    Participants will receive bevacizumab on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Bevacizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Active Comparator: Placebo + Paclitaxel/Carboplatin
    Participants will receive bevacizumab matching placebo on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab matching placebo on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Placebo
Zhou C, Wu YL, Chen G, Liu X, Zhu Y, Lu S, Feng J, He J, Han B, Wang J, Jiang G, Hu C, Zhang H, Cheng G, Song X, Lu Y, Pan H, Zheng W, Yin AY. BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
276
August 30, 2017
August 30, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (Stage IIIb, IV or recurrent disease)
  • Mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Evidence of tumor invading major blood vessels on imaging
  • Central nervous system (CNS) metastases, even if previously treated
  • History of hemoptysis in the 3 months prior to enrollment
  • History or evidence of inherited bleeding diathesis or coagulopathy
  • Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy
  • Clinically significant cardiovascular or vascular disease
  • Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01364012
YO25404
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP